THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
CHEMOTHERAPY PROTOCOLS
V10.0
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CCC Chemotherapy Protocols
2012
General observations ................................................................................................................................. 5 Protocol Additions 2012............................................................................................................................. 5 Cancer Drugs Fund ................................................................................................................................... 5 Off Protocol Treatment Policy ................................................................................................................... 5 Trials .......................................................................................................................................................... 5 Co-payments / top-ups / additional private care........................................................................................ 5 Dose Capping............................................................................................................................................ 6 Breast Cancer.............................................................................................................................................. 7 Adjuvant..................................................................................................................................................... 7 Neo-adjuvant ........................................................................................................................................... 11 Advanced disease ................................................................................................................................... 12 Patients with compromised liver or marrow function............................................................................... 16 Bone directed therapy ............................................................................................................................. 18 Management of patients with HER2 positive cancers............................................................................. 19 Gastrointestinal Cancer............................................................................................................................ 21 Oesophageal Carcinoma......................................................................................................................... 21 Adjuvant ............................................................................................................................................... 21 Neoadjuvant......................................................................................................................................... 21 Gastric / Adenocarcinomas of Gastro-oesophageal junction Carcinoma ............................................... 24 Neoadjuvant / Adjuvant........................................................................................................................ 24 Adjuvant ............................................................................................................................................... 24 Pancreatic cancer.................................................................................................................................... 28 Adjuvant ............................................................................................................................................... 28 Cholangiocarcinoma / Gall Bladder Carcinoma ...................................................................................... 31 Advanced ............................................................................................................................................. 31 Hepatocellular carcinoma* ...................................................................................................................... 33 Neuroendocrine tumours ......................................................................................................................... 34 Colorectal ................................................................................................................................................ 36 Adjuvant ............................................................................................................................................... 36 Rectal cancer - Chemoradiation.............................................................................................................. 38 Advanced Colorectal Cancer................................................................................................................... 39 Anal Carcinoma ....................................................................................................................................... 47 Gynaecological Cancer ............................................................................................................................ 49 Epithelial Ovarian Cancer........................................................................................................................ 49 Epithelial Ovarian Cancer – Mucinous Histology .................................................................................... 56 Endometrial Carcinoma ........................................................................................................................... 58 Cervical Cancer ....................................................................................................................................... 60 Adjuvant ............................................................................................................................................... 60 Haematological Malignancies .................................................................................................................. 65 Issue Date:
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Hodgkins disease .................................................................................................................................... 65 Non-Hodgkins Lymphoma....................................................................................................................... 67 Head and Neck Cancer ............................................................................................................................. 72 Nasopharyngeal Carcinoma.................................................................................................................... 75 Thyroid Cancer ........................................................................................................................................ 76 Lung Cancer ..............................................................................................................................................77 Small Cell ................................................................................................................................................ 77 Non-Small Cell Lung Cancer ................................................................................................................... 80 Mesothelioma ............................................................................................................................................ 87 Melanoma................................................................................................................................................... 88 Sarcomas ................................................................................................................................................... 89 Soft Tissue Sarcoma ............................................................................................................................... 89 Adjuvant ............................................................................................................................................... 89 Neo-adjuvant........................................................................................................................................ 89 Osteosarcoma / MFH of bone / Leiomyosarcoma of Bone ..................................................................... 91 Advanced Osteosarcoma ........................................................................................................................ 93 Ewings Sarcoma...................................................................................................................................... 94 Neoadjuvant......................................................................................................................................... 94 Aggressive fibromatosis .......................................................................................................................... 99 Rhabdomyosarcoma ............................................................................................................................... 99 IVADo Regime for High Risk Rhabdomyosarcoma............................................................................... 101 Gastro-intestinal Stromal Tumours (GIST)............................................................................................ 103 Urological Cancer ................................................................................................................................... 104 Bladder Cancer - Transitional cell ......................................................................................................... 104 Renal cancer ......................................................................................................................................... 108 Prostate Cancer..................................................................................................................................... 111 Germ Cell Tumours ............................................................................................................................... 113 Adjuvant ............................................................................................................................................. 113 Primary CNS Malignancy ....................................................................................................................... 117 Adjuvant Temozolomide .................................................................................................................... 117 Primary CNS Lymphoma ........................................................................................................................ 121 Adenocarcinoma of Unknown Primary Origin ..................................................................................... 124 CCC Emergency Chemotherapy Drugs ................................................................................................ 125 Bone Metastases..................................................................................................................................... 126 CCC anti-emetic guidelines for cytotoxic chemotherapy ................................................................... 127 GCSF ........................................................................................................................................................ 130 Primary Prophylaxis............................................................................................................................... 130 Secondary Prophylaxis.......................................................................................................................... 130 Erythropoietin.......................................................................................................................................... 132 Intrathecal (IT) Chemotherapy ............................................................................................................... 133 Creatinine Clearance .............................................................................................................................. 134 Issue Date:
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Calvert formula for Carboplatin dosage ............................................................................................... 134 Cisplatin dose guidelines....................................................................................................................... 134 Cisplatin Hydration Policy...................................................................................................................... 135 Haematological Indices – Guidelines for the administration of chemotherapy ............................... 136 Capecitabine-........................................................................................................................................... 136 Renal function recommendations ......................................................................................................... 136 Neutropenic Sepsis Policy ..................................................................................................................... 137 Platelet Transfusion Policy .................................................................................................................... 138 Hypocalcaemia ........................................................................................................................................ 138 Hypomagnesaemia ................................................................................................................................. 138 Ifosfamide Encephalopathy and Methylene Blue ................................................................................ 139 Ifosfamide Renal Toxicity....................................................................................................................... 139 Folinic acid rescue for High Dose Methotrexate ................................................................................. 140 CCC Dose Banding Policy...................................................................................................................... 140 Surface Area Nomogram ........................................................................................................................ 148
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General observations There is now an electronic version of the protocol book which is available on CCO Comms and the CCC internet site. This will be updated as required during the year and represents the working version of the book. The paper version will continue but will only be updated annually.
Protocol Additions 2012 Maintenance pemetrexed in advanced NSCLC
Pazopanib in advanced renal cell carcinoma
Gefitinib in advanced NSCLC
In addition we have included all drugs currently funded by the Cancer Drugs Fund. Please refer to the NW Cancer Drugs Fund website for the latest funding policy and conditions for approval. Please note that there may be a 90 day period before a NICE approved drug is funded routinely and therefore doesn’t need a CDF application.;
Cancer Drugs Fund A number of treatments are now available via the Cancer Drugs Fund. The process for accessing the fund is as follows:
•
Complete the relevant application form which can be found on the North West Cancer Drugs Fund web site. The easiest way to find this is to type “nw cancer drugs fund” into google and select the application forms button in the header on the home page.
•
E-mail the completed form to the pharmacy dept at CCC using:
[email protected] this address can be found by typing cco pharmacists into the address book in outlook.
Off Protocol Treatment Policy Inevitably situations will arise that are not covered by the standard CCC protocols. Consultants who wish to use a non-protocol regimen should complete the non-protocol treatment form and submit it to the Clinical Director for Chemotherapy for approval at least 5 days prior to the date of cycle 1 of the proposed treatment. All reasonable requests will be granted.
Trials Entry to clinical trials should be considered for all patients but individual studies have not been listed due to frequent changes.
Co-payments / top-ups / additional private care The uptake of co-payments has been minimal and has been further reduced by the introduction of the Cancer Drugs Fund. However the process is still in place and is outlined below. Issue Date:
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Co-payment refers to top-up funding by an NHS patient for an otherwise unavailable treatment. NHS policy allows patients to fund elements of their care not currently available on the NHS without losing their entitlement to continue with free NHS care.
The CCC co-payments policy considers access to systemic cancer treatments - chemotherapy or targeted therapies - that are currently not funded for use in NHS patients. A copy of the policy can be obtained from pharmacy or found on the CCC website and includes all the required documentation:
•
Co-payment algorithm
•
Additional Private Treatment Form
•
Patient information leaflet.
•
Financial agreement forms.
The self-funded drug may be a single agent or given in combination with standard treatments, in which case the costs incurred relate only to the self-funded drug. However it should always be clear which components of treatment are privately funded and which are provided as NHS treatments.
The patient commits to self-funding the treatment for the duration of the entire programme under supervision by the responsible consultant i.e. a specific number of cycles or indefinite period while there is evidence of a maintained benefit and response. This will include the costs of treatment preparation and delivery, payment of any investigations needed, and any supportive care drugs given as a direct consequence of receiving the self-funded treatment.
Dose Capping In line with ASCO guidelines we have removed routine dose capping for patients with a surface area in 2
excess of 2m .
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Breast Cancer Adjuvant Epi-CMF 2
Epirubicin 100mg/m IV day 1 repeated at 21 day intervals x 4 cycles
followed by CMF x 4 cycles
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • LV ejection fraction prior to cycle 1 if history of cardiac problems • FBC prior to each cycle. CMF
2
Cyclophosphamide
100mg/m po 2
Methotrexate
40mg/m IV
days 1 and 8
2
Fluorouracil
days 1-14 in divided doses
600mg/m IV
days 1 and 8
For patients unable to tolerate oral cyclophosphamide substitute 2
IV cyclophosphamide 600mg/m days 1 and 8
Folinic acid rescue not normally required unless patients develop signs of Methotrexate toxicity, then 15mg 6 hourly x 6 doses starting 24hrs post Methotrexate with subsequent cycles
Cycles are repeated at 28 days from day 1 to a total of 6 cycles.
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion but Methotrexate is hazardous in the presence of renal insufficiency • FBC prior to each cycle, not required on day 8 • Standard FBC limits for administration apply AC
2
2
Doxorubicin 60mg/m + cyclophosphamide 600mg/m IV day 1 repeated at 21 day intervals for 4 cycles has been shown to be equivalent to 6 cycles of CMF.
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Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • LV ejection fraction prior to cycle 1 if history of cardiac problems • FBC prior to each cycle • Standard FBC limits for administration apply 2
2
EC Epirubicin 90mg/m IV + cyclophosphamide 600mg/m IV day 1 repeated at 21 day intervals for 4 cycles. Alternative to AC in this situation
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • LV ejection fraction prior to cycle 1 if history of cardiac problems • FBC prior to each cycle • Standard FBC limits for administration apply FEC / Docetaxel This protocol is available for node positive or high risk node negative patients.
Patients should receive primary prophylaxis with pegfilgrastim after each cycle
FEC
2
Fluorouracil
500mg/m IV day 1
Epirubicin
100mg/m IV day 1
Cyclophosphamide
500mg/m IV day 1
2 2
Repeat at 21 day intervals for 3 cycles
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • LV ejection fraction prior to cycle 1 if history of cardiac problems • FBC prior to each cycle • Standard FBC limits for administration apply Followed by
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2
Docetaxel 100 mg/m IV x 3 cycles at 21 day intervals
Pre-medication: Dexamethasone 8mg oral bd x 3 days start 24hrs pre-docetaxel
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Standard FBC limits for administration apply NB: See section on advanced disease for dose modifications and precautions.
Trastuzumab For patients with HER2 positive cancers
•
Non-metastatic potentially operable primary invasive breast cancer
•
HER2 positive (IHC 3+ and / or FISH positive)
•
Completed definitive surgery and radiotherapy
•
Completed at least 4 cycles of adjuvant or neoadjuvant chemotherapy
•
Within 9 weeks of chemotherapy / radiotherapy / surgery, whichever is last.
•
ECOG PS 0 or 1
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Baseline LVEF normal after completing anthracycline chemotherapy
•
No serious cardiac illness
Trastuzumab
8mg/kg IV loading dose over 90min then 6mg/kg over 60min and thereafter over 30 min every 3 weeks for 12 months (18 cycles) if no problems. May be given concurrently with docetaxel.
Stop at any time if CCF develops
LVEF at 3, 6, 9 and 12 months Stop trastuzumab if LVEF falls by 10 points or to 60
4.0mg
50 - 60
3.5mg
40 - 49
3.3mg
30 –39
3.0mg
< 30
no treatment
Serum creatinine should be repeated every 4 weeks and if it rises significantly during treatment zoledronic acid should be witheld until the creatinine has returned to within 10% of the baseline prior to starting.
For patients with creatinine clearance < 30ml/min ibandronic acid 50mg weekly oral may be considered.
*This is available via the off-protocol mechanism
*Denosumab
120mg sc monthly
Criteria
Patients ineligible for IV bisphosphonate due to poor venous access or renal impairment
*NB available via the Cancer Drugs fund
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Management of patients with HER2 positive cancers Trastuzumab
4 mg/kg loading dose IV. over 90 minutes followed by 2mg/kg/week IV over 30 minutes for 8 doses then 6mg/kg every 3 weeks over 30minutes.
or
8mg/kg IV loading dose over 90min then 6mg/kg over 60min for one dose and then over 30 min thereafter if no problems every 3 weeks
Criteria:
Strongly HER2 positive (HER2 3+ by IHC or FISH positive) Trastuzumab given together with a taxane or vinorelbine as first or second line treatment or second / third line as a single agent.
NB not with anthracycline and with care within close proximity to anthracycline therapy (< 6 months).
LVEF: baseline ECHO/MUGA + 3 monthly repeat advised for patients receiving treatment with trastuzumab.
*Lapatinib (Tyverb®) + capecitabine
Lapatinib 1250mg po daily continuously + 2
Capecitabine 1000mg/m oral twice daily for 14 days followed by 7 days off or 2
850mg/m twice daily for 14 days followed by 7 days offif heavily pre-treated or elderly
NB see capecitabine renal function recommendations p130
Repeat at 21 days until progression or toxicity. For some responding patients continuing with lapatinib alone may be the right approach if capecitabine toxicity becomes unacceptable.
Criteria
Prior anthracycline, taxane and trastuzumab PS 0-2 IHC 3+ or FISH positive cancer
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Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply *Available via the Cancer Drug Fund *Paclitaxel Albumin (Abraxane®) 260mg/m2 IV repeat at 21 day intervals
Consider if no longer safe to continue with paclitaxel or docetaxel. Patients may be able to receive Abraxane® with premedication and appropriate precautions.
Criteria Metastatic breast cancer Situations where taxanes are indicated
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply *Available via the Cancer Drugs Fund
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Gastrointestinal Cancer Oesophageal Carcinoma Adjuvant Not currently recommended as standard therapy Neoadjuvant Cisplatin/5FU
Cisplatin
80mg/m2 IV
day 1
Fluorouracil
1g/m2 over 24hrs IV
days 1-4
or Capecitabine
1000mg/m2 bd x 14 days
Repeat at 21 days for two cycles.
Criteria
PS 0-1 Cr Cl > 50ml/min Operable oesophageal cancer
Laboratory Investigations Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Locally advanced
Chemo-radiation protocol
Cisplatin/5FU
2
Cisplatin
80mg/m IV day 1 and 29
Fluorouracil
1g/m IV over 24hrs days 1-4 and 29-32
2
or Capecitabine
2
825mg/m oral bd Mon-Fri during XRT
+ XRT followed by two additional cycles after completion of XRT
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Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Cisplat/Capecitabine + XRT (SCOPE trial protocol) 2
Cisplatin 60mg/m IV
day 1
+ 2
Capecitabine 625mg/m oral bd
days 1-21
NB see capecitabine renal function recommendations p130
Repeat at 21 day intervals for 4 cycles with radiotherapy concurrent with cycles 3 and 4
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply
Metastatic Cisplatin/5FU
2
Cisplatin
80mg/m IV
Fluorouracil
day 1
2
1g/m IV over 24hrs
days 1-4
or Capecitabine
2
1000mg/m bd x 14 days
Repeat at 21 day intervals, max 4-6 cycles
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Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply
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Gastric / Adenocarcinomas of Gastro-oesophageal junction Carcinoma Neoadjuvant / Adjuvant For patients with operable cancers after initial staging
ECF/X x 3 cycles Surgery -- ECF/X x 3 cycles ECF/X
Epirubicin Cisplatin Fluorouracil
2
50mg/m IV 2
60mg/m IV
day 1 day 1
2
200mg/m / day via continuous IV infusion for 21 days or 2
Capecitabine 625mg/m bd
days 1-21
NB see capecitabine renal function recommendations p130 Repeat at 21 day intervals
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Adjuvant EOF/X
Epirubicin
2
50mg/m IV 2
day 1
Oxaliplatin
130mg/m IV
Fluorouracil
200mg/m / day via continuous IV infusion for 21 days
day 1
2
or Capecitabine 625mg/m2 bd
days 1-21
NB see capecitabine renal function recommendations p130
Repeat at 21 day intervals for a maximum of 6 cycles Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Issue Date:
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Locally advanced / metastatic ECF/X
Epirubicin Cisplatin Fluorouracil
2
50mg/m IV 2
60mg/m IV
day 1 day 1
2
200mg/m / day via continuous IV infusion for 21 days or 2
Capecitabine 625mg/m bd
days 1-21
NB see capecitabine renal function recommendations p130
Repeat at 21 day intervals for a maximum of 4-6 cycles
Laboratory investigations Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply EOF/X
Epirubicin Oxaliplatin Fluorouracil
2
50mg/m IV 2
130mg/m IV
day 1 day 1
2
200mg/m / day via continuous IV infusion for 21 days or
Capecitabine 625mg/m2 bd
days 1-21
NB see capecitabine renal function recommendations p130
Repeat at 21 day intervals for a maximum of 4-6 cycles
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Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Cisplatin/fluoropyrimidine/Herceptin 2
80mg/m IV day 1
Cisplatin
2
Fluorouracil 1g/m over 24hrs IV days 1-4 or 2
Capecitabine 1000mg/m bd x 14 days
Repeat at 21 day intervals for 6 cycles
Herceptin
8mg/kg IV day 1 loading dose 6mg/kg IV every 21 days until progression
Criteria
PS 0-1 Cr Cl > 50ml/min HER 2 status IHC 3+ or FISH positive
Laboratory Investigations Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply
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*Cisplatin/Teysuno 2
75mg/m IV day 1
Cisplatin
2
Teysuno 25mg/m bd po for 21 days
Repeat at 28 day intervals for up to 6 cycles
Criteria
PS 0-1 Cr Cl > 50ml/min Intolerant of capecitabine / 5FU or at high risk of cardiac toxicity
Laboratory Investigations Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines Where renal / hepatic function are abnormal treatment is at physician discretion FBC prior to each cycle Normal FBC limits for administration apply *available via the off protocol mechanism
Second line
Irinotecan
2
250mg/m IV day one of a 21 day cycle repeat x 4 cycles 2
Option to increase to 350mg/m if well tolerated
atropine 600micrograms s/c prior to irinotecan
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply
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Pancreatic cancer Adjuvant Fluorouracil+Folinic acid
Fluorouracil 425mg/m2 IV
daily days 1-5
Folinic acid 50mg IV
daily days 1-5
Cycles are repeated at 28 days for 6 cycles.
NB: For patients over 70yrs and those with borderline performance status the dose of Fluorouracil should be reduced to 370mg/m2 per day.
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Gemcitabine
1g/m
2
IV weekly for 3 weeks followed by one week break Repeat 28 day cycles for up to 6 cycles.
Criteria
PS 0-2 R0, R1 resection M0
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated NB: transaminases may rise during gemcitabine therapy • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Advanced
First line
Gemcitabine + Capecitabine Gemcitabine Capecitabine
1g/m
2
825mg/m
IV days 1, 8, 15 2
po bd for 21 days
NB see capecitabine renal function recommendations p130 Repeat 28 day intervals for up to 6 cycles.
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Criteria
PS 0-1
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated NB: transaminases may rise during gemcitabine therapy • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • CA19-9 every 4 weeks • Day 8 or 15
9
Platelets 75 – 99 x10 /l continue at full dose 9
Platelets < 75x10 /l omit gemcitabine Gemcitabine
1g/m
2
IV weekly for 3 weeks followed by one week break Repeat 28 day cycles for up to 6 cycles. or IV weekly for seven weeks followed by one week break for first cycle then 3 weeks on, one off as above.
Criteria
PS 0-2
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated NB: transaminases may rise during gemcitabine therapy • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • CA19-9 every 4 weeks • Day 8 or 15
9
Platelets 75 – 99 x10 /l continue at full dose 9
Platelets < 75x10 /l omit gemcitabine Second line Ox-Cap
2
Oxaliplatin
85 mg/m IV day 1
Capecitabine
900mg/m oral bd x 9 days
2
NB see capecitabine renal function recommendations p130
Repeat at 14 day intervals for 6 cycles then reassessment
Criteria
PS 0-2 Relapse < 6 months post adjuvant chemotherapy Progression free interval > 3 months following first line therapy
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Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC and creatinine prior to each cycle • Normal FBC limits for administration apply with the exception that the lower limit for 9
platelets for administration of Ox-Cap is 75 x 10 /l
OxMdG
2
Oxaliplatin
85 mg/m IV
Folinic acid
350mg flat dose two hour IV infusion day 1
Fluorouracil
400mg/m 15 minute IV bolus
Fluorouracil
day 1
2
2
2400mg/m 46hr IV infusion start
day 1 day 1
Repeat at 14 day intervals for 6 cycles then reassessment
Avoid in patients with pre-existing neuropathy
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply with the exception that the lower limit for 9
platelets for administration of OxMdG is 75 x 10 /l
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Cholangiocarcinoma / Gall Bladder Carcinoma Advanced Gemcitabine + Cisplatin 2
Gemcitabine
1000mg/m day 1 and 8
Cisplatin
25mg/m
2
day 1 and 8
Repeat at 21 day intervals for a maximum of 6 cycles
Criteria PS 0-1
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Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • CA19-9 every 4 weeks • Normal FBC limits for administration apply
Gemcitabine
1g/m
2
IV weekly for 3 weeks followed by one week break Repeat 28 day cycles for 4- 6 cycles.
Criteria
PS 0-2
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • CA19-9 every 4 weeks • Normal FBC limits for administration apply ECF/EOX
Epirubicin Cisplatin Fluorouracil
2
50mg/m IV 2
60mg/m IV
day 1 day 1
2
200mg/m / day via continuous IV infusion or
Oxaliplatin Epirubicin
2
130mg/m IV 2
50mg/m IV 2
Capecitabine 625mg/m bd
day 1 day 1 days 1-21
NB see capecitabine renal function recommendations p130
Repeat at 21 day intervals for a maximum of 4-6 cycles
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Issue Date:
th
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Hepatocellular carcinoma* Sorafenib
Sorafenib Initial dose 200mg bd increasing to 400mg bd over 4 weeks to 400mg bd oral continuously
Continue until disease progression
Criteria
PS
0-2 Normal bilirubin Transaminases < 2xULN Normal renal function
Laboratory investigations •
FBC, U/Es, LFTs prior to each cycle
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
Discontinue if deteriorating renal or liver function
•
Normal FBC limits for administration apply
*NB Available via the Cancer Drugs
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Neuroendocrine tumours High mitotic rate, anaplastic histology, clinically aggressive
Etoposide / cisplatin
2
Etoposide
120mg/m IV
Cisplatin
70mg/m IV
2
days 1-3 days 1
Repeat at 21 day intervals max 6 cycles
Criteria
PS 0-1 Cr cl > 50ml/min Patients with rapidly progressive disease
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Low mitotic rate, well differentiated histology, clinically indolent
Somatostatin short acting analogue titrated to achieve maximum benefit then switch to long acting preparation
Pancreatic neuroendocrine tumours
*Everolimus (Afinitor®)
10mg oral daily
Laboratory Investigations •
Ensure normal renal and hepatic function prior to each cycle 1
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
Criteria
*NB
*Sunitinib (Sutent®) Issue Date:
30th October 2012
Author: Dr. D.B. Smith
First or Second line therapy
Available via the Cancer Drug Fund
37.5mg oral daily Page 34 of 148
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Laboratory Investigations •
Ensure normal renal and hepatic function prior to each cycle 1
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
Criteria
*NB
No prior anti-VEGF therapy
Available via the Cancer Drugs Fund
Progression on first line therapy
Streptozotocin/Doxorubicin Streptozotocin Doxorubicin
2
500mg/m IV 50mg/m
2
days 1-5 repeat every 6 weeks
IV
day 1 repeat every 3 weeks
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply
*Octreotide
Octreotide LAR 20-30mg IM monthly
Criteria non-functioning neuroendocrine tumour of mid gut or uncertain primary origin Locally inoperable or metastatic disease Well differentiated histology
*Available via the Cancer Drugs Fund
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Colorectal Adjuvant 5FU/FA
2
Fluorouracil 370mg/m IV + folinic acid 50 mg IV weekly x 24 weeks
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to every fourth week • Normal FBC limits for administration apply Capecitabine
2
1250mg/m oral twice daily for 14 days followed by 7 days off 2
Consider 1000mg/m for patients over 70yrs
NB see capecitabine renal function recommendations p130 Repeat at 21 days from day 1 for eight cycles.
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Repeat creatinine if clinically indicated • Normal FBC limits for administration apply XELOX
2
Oxaliplatin
130 mg/m IV day 1
Capecitabine
1000mg/m oral bd x 14 days
2
NB see capecitabine renal function recommendations p130
Repeat at 21 day intervals for 8 cycles then reassessment
Consider carefully in patients with pre-existing neuropathy
Consider omitting oxaliplatin if persistent neuropathy develops.
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Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated. • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle. • Normal FBC limits for administration apply. OxMdG
2
Oxaliplatin
85 mg/m IV
Folinic acid
350mg flat dose two hour IV infusion day 1
Fluorouracil
400mg/m 15 minute IV bolus
Fluorouracil
day 1
2
2
2400mg/m 46hr IV infusion
day 1 start day 1
Repeat at 14 day intervals for 12 cycles
Consider carefully in patients with pre-existing neuropathy
Consider omitting oxaliplatin if persistent neuropathy develops.
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply with the exception that the lower limit for 9
platelets for administration of OxMdG is 75 x 10 /l
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Rectal cancer - Chemoradiation 2
5FU + XRT
Fluorouracil 1000mg/m IV days 1-4 and 22-26 (or final week)
Or 2
Fluorouracil 300mg/m + Folinic acid 50mg IV weekly during the radiotherapy
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Capecitabine + XRT
2
Capecitabine 825mg/m oral bd Mon-Fri during XRT NB see capecitabine renal function recommendations p130
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC each week during chemotherapy • Normal FBC limits for administration apply 2
5FU/FA
Fluorouracil 300mg/m IV + folinic acid 50 mg IV weekly during XRT
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to every fourth week • Normal FBC limits for administration apply
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Advanced Colorectal Cancer First line
Single agent
MdG
MdG:
Folinic acid 350mg flat dose two hour IV infusion day 1 2
Fluorouracil 400mg/m 15 minute IV bolus 2
Fluorouracil 2800mg/m 46hr IV infusion start
day 1 day 1
repeat at 14 day intervals, re-evaluate after 6 cycles.
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Capecitabine
2
1250mg/m oral twice daily for 14 days 2
Consider 1000mg/m if age >70yrs NB see capecitabine renal function recommendations p130
Repeat at 21 day intervals for a maximum of 6 cycles
Laboratory Investigations
Ensure normal renal and hepatic function prior to cycle 1 if clinically indicated
• Where renal / hepatic function are abnormal treatment is at physician discretion • FBC and creatinine prior to each cycle • Normal FBC limits for administration apply Raltitrexed (Tomudex®)
2
3mg/m IV repeat at 21 day intervals for a maximum of 6 cycles
Criteria:
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Patients intolerant of fluoropyrimidines
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Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC and creatinine prior to each cycle • Normal FBC limits for administration apply Combination chemotherapy IrinMdG
2
Irinotecan 180mg/m IV + atropine 600micrograms s/c prior to irinotecan
MdG:
Folinic acid 350mg flat dose two hour IV infusion day 1 2
Fluorouracil 400mg/m 15 minute IV bolus 2
Fluorouracil 2400mg/m 46hr infusion
day 1 start day 1
Repeat at 14 day intervals Review after 12 weeks and consider continuing to 24 weeks if:
•
SD / response.
•
Acceptable toxicity
Criteria: PS 0-2
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply I-Cap
2
Irinotecan 180mg/m IV + atropine 600micrograms s/c prior to irinotecan 2
Capecitabine 900mg/m oral bd x 9 days NB see capecitabine renal function recommendations p130
Repeat at 14 day intervals
Review after 12 weeks and consider continuing to 24 weeks if:
•
SD / response.
•
Acceptable toxicity
Criteria: PS 0-1
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Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC and creatinine prior to each cycle • Normal FBC limits for administration apply OxMdG
2
Oxaliplatin
85 mg/m IV
Folinic acid
350mg flat dose two hour IV infusion day 1
Fluorouracil
400mg/m 15 minute IV bolus
Fluorouracil
day 1
2
2
2400mg/m 46hr IV infusion
day 1 start day 1
Repeat at 14 day intervals for 6 cycles then reassessment
Avoid in patients with pre-existing neuropathy
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply with the exception that the lower limit for 9
platelets for administration of OxMdG is 75 x 10 /l
Ox-Cap
2
Oxaliplatin
85 mg/m IV day 1
Capecitabine
900mg/m oral bd x 9 days
2
NB see capecitabine renal function recommendations p130 Repeat at 14 day intervals for 6 cycles then reassessment
Avoid in patients with pre-existing neuropathy
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC and creatinine prior to each cycle • Normal FBC limits for administration apply with the exception that the lower limit for 9
platelets for administration of Ox-Cap is 75 x 10 /l
XELOX
Issue Date:
2
Oxaliplatin
130 mg/m IV day 1
Capecitabine
1000mg/m oral bd x 14 days
30th October 2012
Author: Dr. D.B. Smith
2
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NB see capecitabine renal function recommendations p130
Repeat at 21 day intervals for 4 cycles then reassessment
Avoid in patients with pre-existing neuropathy
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply. OxMdG + Cetuximab 2
Oxaliplatin
85 mg/m IV
Folinic acid
350mg flat dose two hour IV infusion day 1
Fluorouracil
400mg/m 15 minute IV bolus
Fluorouracil Cetuximab
day 1
2
2
2400mg/m 46hr IV infusion start
day 1 day 1
2
Week 1 500mg/m IV day 1 over 2 hours using 0.2um in-line filter 2
Then 500mg/m IV over 1 hour every 2 weeks
Premedication
Dexamethasone 8mg Chlorphenamine 10mg Ranitidine 150mg
Repeat at 14 day intervals for 6 cycles then reassessment
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC and biochemistry prior to each cycle • Normal FBC limits for administration apply with the exception that the lower limit for 9
platelets for administration of OxMdG is 75 x 10 /l
Criteria
KRAS wild type cancer PS 0-1 Metastatic disease confined to the liver and potentially resectable if downsized Primary resected or resectable Avoid in patients with pre-existing neuropathy
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IrinMdG + Cetuximab 2
Irinotecan
180mg/m IV + atropine 600micrograms s/c prior to irinotecan
Folinic acid
350mg flat dose two hour IV infusion day 1
Fluorouracil
400mg/m 15 minute IV bolus day 1
Fluorouracil
2400mg/m 46hr infusion start day 1
Cetuximab
Week 1 500mg/m IV day 1 over 2 hours using 0.2um in-line filter
2
2
2
2
Then 500mg/m IV over 1 hour every 2 weeks
Premedication
Dexamethasone 8mg Chlorphenamine 10mg Ranitidine 150mg
Repeat at 14 day intervals. Review after 12 weeks and consider continuing to 24 weeks if:
•
SD / response.
•
Acceptable toxicity
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC and biochemistry prior to each cycle • Normal FBC limits for administration apply with the exception that the lower limit for 9
platelets for administration of OxMdG is 75 x 10 /l
Criteria
KRAS wild type cancer PS 0-1 Metastatic disease confined to the liver and potentially resectable if downsized Primary resected or resectable
*Bevacizumab 14 day schedules: 21 day schedules
Criteria
Bevacizumab 5mg/kg IV infusion Bevacizumab 7.5mg/kg IV infusion
Advanced colorectal cancer First line chemotherapy With oxaliplatin or Irinotecan based combination chemotherapy
*NB
Issue Date:
Available via the Cancer Drug Fund
30th October 2012
Author: Dr. D.B. Smith
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Second / third line chemotherapy
Irinotecan + MdG (see above)
Oxaliplatin + MdG (see above)
I-Cap (see above)
Ox-Cap (see above) 2
Irinotecan
180mg/m IV day 1 of a 14 day cycle atropine 600micrograms s/c prior to irinotecan
or 2
350mg/m IV day one of a 21 day cycle atropine 600micrograms s/c prior to irinotecan
Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
*Bevacizumab
14 day schedules:
Bevacizumab 5mg/kg IV infusion
21 day schedules
Bevacizumab 7.5mg/kg IV infusion
Criteria
Advanced colorectal cancer Second line chemotherapy With oxaliplatin based combination chemotherapy
*NB
Available via the Cancer Drug Fund
*Irinotecan + Cetuximab
Criteria - Must have KRAS wild type cancers - Previously responded to chemotherapy - Second or third line chemotherapy - Performance status (0-1) Issue Date:
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Cetuximab
Irinotecan
2
Week 1
500mg/m IV day 1 over 2 hours using 0.2um in-line filter
Then
500mg/m IV over 1 hour every 2 weeks
2
2
180mg/m IV every 2 weeks + atropine 600micrograms s/c
Premedication Dexamethasone 8mg Chlorphenamine 10mg Ranitidine 150mg
Continue until progression / unacceptable toxicity
*Available via the Cancer Drug Fund * Cetuximab single agent Criteria - Must have KRAS wild type cancers - Previously responded to chemotherapy - Third line chemotherapy - Performance status (0,1)
Cetuximab
2
Week 1
500mg/m IV day 1 over 2 hours using 0.2um in-line filter
Then
500mg/m IV over 1 hour every 2 weeks
2
Premedication Dexamethasone 8mg Chlorphenamine 10mg Ranitidine 150mg
Continue until progression / unacceptable toxicity
*Available via the Cancer Drug Fund
MMC + MdG
2
Mitomycin-C 7mg/m IV day 1 repeat every 6 weeks (max 4 doses) + Folinic acid 350mg flat dose two hour infusion 2
Fluorouracil 400mg/m 15 minute IV bolus day 1 2
Fluorouracil 2400mg/m 46hr IV infusion start day 1
Repeated at 14 day intervals
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Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply 2
MMC + Capecitabine Mitomycin-C 7mg/m IV day 1 repeat every 6 weeks, max 4 doses 2
Capecitabine 1000mg/m oral bd for 14 days repeat at 21 day intervals NB see capecitabine renal function recommendations p130
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC and biochemistry prior to each cycle • Normal FBC limits for administration apply
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Anal Carcinoma Localised squamous carcinoma of the anus
Combined XRT + chemotherapy 2
Mitomycin C
12mg/m IV day 1 only (max 20mg)
Fluorouracil
1000mg/m IV over 24hrs days 1-4
Fluorouracil
1000mg/m IV over 24hrs daily x 4 during final week of XRT
2 2
or Capecitabine
2
825mg/m bd oral on each XRT treatment day NB see capecitabine renal function recommendations p130
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Palliative / Metastatic
Cisplatin/5FU
2
Cisplatin
60mg/m IV (max 120mg)
Fluorouracil
2
1g/m IV over 24hrs
day 1 days 1-4
or Capecitabine
2
1000mg/m bd x 14 days
Repeat at 21 day intervals max 4 courses
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply
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Mitomycin C / Fluoropyrimidine 2
Mitomycin C
7mg/m IV day 1 repeat every 6 weeks, max 4 cycles
Fluorouracil
1000mg/m IV over 24hrs days 1-4 repeat at 21 day intervals
2
or Capecitabine
2
1000mg/m bd po days 1-14 repeat at 21 day intervals
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply
Issue Date:
30th October 2012
Author: Dr. D.B. Smith
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Gynaecological Cancer Epithelial Ovarian Cancer First Line Chemotherapy
Paclitaxel/Carboplatin Paclitaxel Carboplatin
Paclitaxel premedication
175mg/m2
IV over 3 hours
AUC 5/6
IV over 1 hour
Chlorphenamine
10mg
Dexamethasone
20mg
Ranitidine
50mg
Repeat at 21 day intervals maximum 6 courses
Criteria
Stage Ib-IV
Minimal residual disease / bulk residual disease PS 0-1 Cr Cl > 50ml/min
Laboratory Investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • CA125 prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply *Paclitaxel/Carboplatin/Bevacizumab 2
Paclitaxel
175mg/m IV over 3 hours
Carboplatin
AUC 5/6 IV over 1 hour
Bevacizumab
7.5mg/kg
Paclitaxel premedication
Chlorphenamine
10mg
Dexamethasone
20mg
Ranitidine
50mg
Repeat at 21 day intervals maximum 6 cycles chemotherapy max 18 cycles bevacizumab Criteria
Stage III (residual disease >1cm) or IV PS 0-1 Cr Cl > 50ml/min
Issue Date:
th
30 October 2012
Author: Dr. D.B. Smith
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Laboratory Investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • CA125 prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply *Available via the cancer drugs Fund
or
Carboplatin
Carboplatin AUC 5/6 x (GFR + 25) IV at 21-28 day intervals x max 6 cycles
Laboratory Investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • CA125 prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply Second line chemotherapy Relapse > 6 months post platinum
Single agent carboplatin Carboplatin AUC 5-6 IV repeated every 28 days x 4-6 cycles
Laboratory Investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • CA125 prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply Issue Date:
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Author: Dr. D.B. Smith
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Single agent cisplatin 2
Cisplatin 80mg/m IV repeated every 21 days x 4-6 cycles
Laboratory Investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • CA125 prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply Paclitaxel + carboplatin st
See 1 line section for doses + pre-medication schedule
Repeat at 21 day intervals, max 6 doses
Laboratory Investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • CA125 prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply Carboplatin + Gemcitabine Carboplatin
AUC4 IV at 21 day intervals
Gemcitabine
1000mg/m IV days 1 and 8 of a 21 day cycle
2
Repeat at 21 day intervals to a maximum of 6 cycles • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • CA125 prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply Issue Date:
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Carboplatin + Liposomal Doxorubicin (Caelyx®) Carboplatin
AUC5
Liposomal Doxorubicin (Caelyx®)
30mg/m IV
2
Repeat at 28 day intervals to a maximum of 6 cycles
• Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • CA125 prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply Single agent Paclitaxel 2
70mg/m IV weekly
Paclitaxel
Pre-medication Dexamethasone
8mg IV before first cycle 4mg IV before second and subsequent cycles
Chlorphenamine
10mg IV
Ranitidine
50mg IV
Laboratory investigations • Ensure normal renal function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Patients with abnormal hepatic function should be treated cautiously • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle. • Normal limits for administration apply with the exception that for patients with marrow infiltration treatment may be continued at lower platelet and neutrophil counts at treating physician discretion.
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Second / Third line chemotherapy options 2
Paclitaxel 175mg/m IV over 3hrs or 2
135mg/m IV over 3hrs (depending on PS / prior treatment)
Premedication
Chlorphenamine
10mg IV
Dexamethasone
20mg IV
Ranitidine
50mg IV
Repeat at 21 day intervals, max 6 cycles
Criteria PS 0-1 No prior taxane therapy Previous platinum 2
Liposomal doxorubicin (Caelyx®) 40-45mg/m by IV infusion initially at 1mg/min q 28 days Maximum 6 cycles
Criteria
PS 0-2 Platinum resistant / refractory No evidence of intestinal obstruction
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • CA125 prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply Topotecan
2
1.25mg/m daily IV over 30 minutes for 5 days q 21 days or 2
3mg/m IV weekly on days 1, 8, 15 of a 28 day cycle
Maximum 4 cycles
Criteria
PS 0-2 Platinum resistant / refractory Cr Cl > 40ml/min
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Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • CA125 prior to each cycle • FBC prior to each dose • Normal FBC limits for administration apply 2
Gemcitabine
1000mg /m IV days 1,8,15 of a 28 day cycle. Criteria
PS 0-2
Platinum resistant / refractory
Reassess after 3 cycles, maximum 6 cycles
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • CA125 prior to each cycle • FBC prior to each dose • Normal FBC limits for administration apply Etoposide
50mg bd oral x 7days of 21 day cycle max 6 cycles
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • CA125 prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply Chlorambucil
10mg daily oral x 14 days of 28 day cycle max 6 cycles
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • CA125 prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply Issue Date:
th
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Doxorubicin
2
60mg/m IV q21 days, max 6 cycles
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • CA125 prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply • Consider LV ejection fraction if history of cardiac disease
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Epithelial Ovarian Cancer – Mucinous Histology First line
Carboplatin / Paclitaxel or single agent carboplatin
Platinum refractory 2
Capecitabine 1250mg/m oral twice daily for 14 days NB see capecitabine renal function recommendations p130
Repeat at 21 day intervals for a maximum of 6 cycles
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC and creatinine prior to each cycle • Normal FBC limits for administration apply Capecitabine should be the treatment of choice where a central line is contra-indicated eg
I-Cap
•
Failed central venous catheterisation
•
Receiving anticoagulants but NB interaction between warfarin and capecitabine 2
Irinotecan 180mg/m IV + atropine 600micrograms s/c prior to irinotecan 2
Capecitabine 900mg/m oral bd x 9 days NB see capecitabine renal function recommendations p130
Repeat at 14 day intervals
Review after 12 weeks and consider continuing to 24 weeks if:
•
SD / response.
•
Acceptable toxicity
Criteria: PS 0-1
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC and creatinine prior to each cycle Issue Date:
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• Normal FBC limits for administration apply Ox-Cap
2
Oxaliplatin
85 mg/m IV day 1
Capecitabine
900mg/m oral bd x 9 days
2
NB see capecitabine renal function recommendations p130
Repeat at 14 day intervals for 6 cycles then re-assessment
Avoid in patients with pre-existing neuropathy
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC and creatinine prior to each cycle • Normal FBC limits for administration apply with the exception that the lower limit for 9
platelets for administration of Ox-Cap is 75 x 10 /l
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Endometrial Carcinoma Epithelial
Advanced
Doxorubicin/Cisplatin/Paclitaxel 2
Doxorubicin
45mg/m IV 2
day 1
IV
day 1
Paclitaxel
160mg/m IV
day 2
Premedication
Chlorphenamine
10mg
Dexamethasone
20mg
Ranitidine
50mg
Cisplatin
50mg/m
2
Maximum of 6 cycles at 21 day intervals
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Mixed Mullerian Tumours
Doxorubicin
2
Doxorubicin 75mg/m IV at 21 day intervals x 6 cycles depending on response
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply • Consider LV ejection fraction if history of cardiac disease or 2
Cisplatin Cisplatin 80mg/m IV at 21 day intervals x 6 cycles
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Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply or 2
Doxorubicin/Cisplatin
Doxorubicin 50mg/m IV Cisplatin
2
50mg/m IV
Maximum of 6 cycles at 21 day intervals
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply • Consider LV ejection fraction if history of cardiac disease
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Cervical Cancer Adjuvant Not currently recommended as standard therapy
Pre-XRT
BMC
Bleomycin
30,000 iu IV day 1
Mitomycin-C
10mg/m IV cycles 1,3
Cisplatin
50mg/m IV day 1
2 2
Repeat every 14 days for 2-4 cycles
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Advanced Squamous Carcinoma
Cisplatin / Topotecan Criteria
1.
>6m from completion of chemo-radiation to relapse
2.
no prior radiosensitising cisplatin
3.
PS 0-1 2
Cisplatin
50mg/m IV
day 1
2
Topotecan
0.75mg/m IV
days 1-3
Repeat at 21 day intervals for 4-6 cycles
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Issue Date:
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Paclitaxel/Cisplatin 2
Paclitaxel
135mg/m IV over 3 hours
Cisplatin
50mg/m IV
2
Paclitaxel premedication
Chlorphenamine
10mg
Dexamethasone
20mg
Ranitidine
50mg
Repeat at 21 day intervals maximum 6 courses
Criteria
1.
>6m from completion of chemo-radiation to relapse
2.
no prior radiosensitising cisplatin
3.
PS 0-1
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply 2
Topotecan
Topotecan 1.2mg/m (max 2mg) IV days 1-5
Repeat at 28 day intervals for 4-6 cycles
Criteria
1.
PS 0-2
2.
50mls/min
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Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply XRT + Cetuximab 2
400mg/m IV loading dose 1 week prior to XRT
Cetuximab
2
250mg/m IV weekly during XRT
Criteria
Locally advanced SCC suitable for CTX/XRT Unsuitable for cisplatin eg creatinine clearance < 50mls/min PS 0/1
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Recurrent or Metastatic Disease
Cisplatin/5FU
2
Cisplatin
80mg/m IV
day 1
2
Fluorouracil
1g/m IV over 24hrs
days 1-4
or
Cisplatin
2
100mg/m IV
Cisplatin
Repeat at 21 day intervals max 6 cycles
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Issue Date:
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*Cisplatin or Carboplatin + /5FU + Cetuximab Cisplatin/5FU
2
80mg/m IV
Cisplatin 5Fluorouracil
day 1
2
1g/m IV over 24hrs
days 1-4
Repeat at 21 day intervals max 6 cycles Or Carboplatin/5FU
Carboplatin
AUC 5
Day 1
Fluorouracil
1g/m IV over 24hrs
2
Days 1-4
Repeat at 21 day intervals max 6 cycles 2
Cetuximab
400mg/m IV loading dose week 1 2
250mg/m IV weekly during chemotherapy and may be continued until progression
Criteria
Ist line chemotherapy for advanced disease PS 0/1
No prior treatment with cetuximab
Laboratory investigations Ensure normal hepatic function prior to cycle 1 and repeat during
•
subsequent cycles if clinically indicated Calculate creatinine clearance prior to each cycle and administer
•
cisplatin according to guidelines Where renal / hepatic function are abnormal treatment is at physician
•
discretion •
FBC prior to each cycle
•
Normal FBC limits for administration apply
*Available via the cancer drugs fund nd
2
Line Chemotherapy for advanced disease
Paclitaxel
2
135-175mg/m IV over 3hrs
Dose depends on PS and extent of prior therapy
Premedication
Chlorphenamine
10mg IV
Dexamethasone
20mg IV
Ranitidine
50mg IV
Repeat at 21 day intervals, max 6 cycles Criteria Issue Date:
PS 0-1
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Nasopharyngeal Carcinoma Chemoradiation + Adjuvant Chemotherapy Criteria Nasopharyngeal carcinoma Stage III/IV Creatinine clearance > 50ml/min
Chemoradiation Cisplatin 100mg/m2 days 1, 22, 43 to start prior to XRT
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply followed by: Adjuvant chemotherapy Commencing 21 days after 3rd cycle of cisplatin 2
Cisplatin
80mg/m IV
day 1
2
Fluorouracil
1g.m IV over 24 hrs
days 1-4
Repeat at 21 day intervals for 3 cycles
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply
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Thyroid Cancer Medullary Thyroid Cancer
*Vandetanib Continue until disease progression
Criteria PS
0-2
Locally advanced unresectable / metastatic First line
Laboratory investigations •
FBC, U/Es, LFTs prior to each cycle
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
Discontinue if deteriorating renal or liver function
Normal FBC limits for administration apply
*NB available via the Cancer Drug
Papillary or Follicular Thyroid Cancer
Sorafenib
400mg bd oral continuously
Continue until disease progression
Criteria PS 0-2 Refractory to radioiodine
Laboratory investigations •
FBC, U/Es, LFTs prior to each cycle
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
Discontinue if deteriorating renal or liver function
•
Normal FBC limits for administration apply
*NB available via the Cancer Drugs fund
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Lung Cancer Small Cell Good PS + Limited stage
Cisplatin/etoposide
2
2
Etoposide 120mg/m IV days 1-3 (or PO 240mg/m days 2-3 in 2 divided doses) 2
Cisplatin 70mg/m IV
days 1
Repeat at 21 day intervals max 4 cycles
XRT commences with cycle 2
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Concurrent chemotherapy + XRT Cisplatin + etoposide as above with XRT commencing with cycle 2
Good / Intermediate PS Carboplatin / Etoposide Carboplatin
AUC 5 IV
Etoposide
day 1 2
day 1
2
days 2 and 3
100mg/m IV
Etoposide
200mg/m PO in 2 divided doses
Repeat at 21 day intervals x 4 - 6 cycles
Laboratory Investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle Issue Date:
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• Normal FBC limits for administration apply Poor PS Many poor PS patients will be too ill potentially to benefit from chemotherapy and symptomatic care will be the most appropriate option. For those judged to be fit enough the following may be considered:
(1) Carboplatin
AUC 4 / 5 IV q 21 days x 4 cycles
Laboratory Investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply (2) Etoposide
50mg oral bd x 7 - 10 days repeat at 21 days from day 1max 6 courses
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Second Line Chemotherapy
(1) Etoposide
50mg oral bd x 7 - 10 days repeat at 21 days from day 1max 6 cycles / progression
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply (2) Carboplatin
Issue Date:
AUC x 5-6 IV q 21 days for 4 cycles
30th October 2012
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Laboratory Investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply (3) CAV
2
Cyclophosphamide
750mg/m IV
Doxorubicin
50mg/m IV
Vincristine
1.4mg/m IV
2
2
Repeat at 21 days for 4 – 6 cycles
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply (4) Topotecan 2
2.3mg/m oral daily for 5 days
Repeat at 21 day intervals , maximum 4 cycles
Criteria
PS 0-2 Cr Cl > 40ml/min
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • CA125 prior to each cycle • FBC prior to each dose • Normal FBC limits for administration apply
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Non-Small Cell Lung Cancer Adjuvant Criteria
Stage 1-3 completely resected PS 0-1
Cisplatin/Vinorelbine
Cisplatin
2
80mg/m IV day 1 2
2
Vinorelbine 25mg/m IV day 1 and 8 or oral 60mg/m day 1 and 8
Repeated at 21 day intervals x 3 cycles
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply or Carboplatin/Vinorelbine
Carboplatin AUC x 5 IV 2
2
Vinorelbine 25mg/m IV days 1 and 8 or 60mg/m oral day 1 and 8
21 – 28 day cycle x 3 cycles
Laboratory Investigations •
Ensure normal hepatic function prior to cucle 1 and repeast during subsequent cycles if clinically indicated.
•
Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if clinically indicated
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
Carboplatin/Vinorelbine (split dose)
Carboplatin AUC x 2.5 IV days 1 and 8 Vinorelbine
25mg/m2 IV days 1 and 8 or 60mg/m2
oral day 1 and 8
21 – 28 day cycle x 3 cycles
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Laboratory Investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Locally advanced 2
Chemotherapy + XRT
Cisplatin 20mg/m IV days 1-4 and 16 - 19 + 2
Vinorelbine 15mg/m IV with XRT fractions 1, 6, 15 and 20 Followed at 4-6 weeks by: Cisplatin 80mg/m
2
Vinorelbine 25mg/m
day 1 2
day 1 and 8
Repeated at 21 day intervals x 2 cycles
Laboratory investigations Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Advanced 2
Cisplatin / Pemetrexed Cisplatin 75mg/m IV 2
Pemetrexed 500mg/m IV
Repeat at 21 day intervals x 4 cycles
•
Vitamin B12 injection IM 1 week prior to start + every 9 weeks until completion
•
Folic acid 400micrograms daily oral during treatment
•
Dexamethasone 4mg bd for 3 days start day before pemetrexed
•
Stop all NSAIDS during chemotherapy
Criteria: Non-squamous carcinomas PS 0-1 Issue Date:
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Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Cisplatin/Vinorelbine
2
80mg/m IV day 1
Cisplatin
2
2
Vinorelbine 25mg/m IV day 1 and 8 (oral vinorelbine 60mg/m day 1and 8)
Repeated at 21 day intervals x 4 cycles
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Gemcitabine/Carboplatin
Carboplatin AUC x 5 IV
day 1
2
Gemcitabine 1250mg/m IV
days 1 and 8
21 – 28 day cycle x 4 cycles
Laboratory Investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated NB: transaminases may rise during treatment • Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply
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Carboplatin/Vinorelbine
Carboplatin Vinorelbine
AUC x 4/5 IV
day 1
2
days 1 and 8
2
days 1 and 8
25mg/m IV
Or oral vinorelbine
60mg/m
21 – 28 day cycle x 4 cycles
Laboratory Investigations Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Vinorelbine
2
25-30mg/m IV days 1 and 8 of a 21 day cycle or 2
60-80mg/m oral days 1 and 8
Max 4 courses
Criteria:
No prior chemotherapy PS 0-2
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Gemcitabine
2
Gemcitabine 1000mg/m IV days 1, 8, 15 of a 28 day cycle
Laboratory Investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated NB: transaminases may rise during treatment • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Issue Date:
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Gefitinib (Iressa®)
Gefitinib
250mg oral daily
Criteria
Locally advanced / metastatic NSCLC EGFR mutation positive First line
Erlotinib (Tarceva®)
Erlotinib
150mg oral daily
Criteria
EGFR mutation positive First line
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Maintenance Pemetrexed Maintenance pemetrexed is available through the normal funding mechanism for patients who fulfil the criteria set out by NICE and who did not receive pemetrexed as part of first line therapy. For those patients who received pemetrexed as part of first line therapy and who fulfil the criteria funding is available via the CDF
Pemetrexed
500mg/m2 IV
Repeat at 21 day intervals until progression
•
Vitamin B12 injection IM 1 week prior to start + every 9 weeks until completion
•
Folic acid 400micrograms daily oral during treatment
•
Dexamethasone 4mg bd for 3 days start day before pemetrexed
•
Stop all NSAIDS during chemotherapy
Criteria: Non-squamous carcinomas PS 0-1 CR/PR/SD following first line chemotherapy First line CTX with Platinum + vinorelbine/paclitaxel/gemcitabine/docetaxel
*Pemetrexed
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Author: Dr. D.B. Smith
500mg/m2 IV
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Repeat at 21 day intervals until progression •
Vitamin B12 1mg injection IM 1 week prior to start + every 9 weeks until completion
•
Folic acid 400micrograms daily oral during treatment
•
Dexamethasone 4mg bd for 3 days start day before pemetrexed
•
Stop all NSAIDS during chemotherapy
Criteria: Non-squamous carcinomas PS 0-1 CR/PR/SD following first line chemotherapy First line chemotherapy with Cisplatin + Pemetrexed
*Available via the Cancer Drugs Fund
Second line Chemotherapy
Docetaxel
75mg/m
2
IV q 21 day cycle x max 4 cycles
Dexamethasone 8mg bd x 3 days start 24hrs pre-docetaxel
Criteria
PS 0-1 Previous response or stable disease to platinum based chemotherapy Progression free interval following platinum based chemotherapy > 6m
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Erlotinib (Tarceva®)
Erlotinib
150mg oral daily initially for 4 weeks and continued thereafter if symptomatic or objective response
Criteria
Issue Date:
-
Progression following chemotherapy for advanced disease
-
Fit to receive docetaxel as second line therapy
-
No prior anti EGFR therapy
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Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply
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Mesothelioma 2
Cisplatin / Pemetrexed Cisplatin 75mg/m IV 2
Pemetrexed 500mg/m IV
Repeat at 21 day intervals for a maximum of 6 cycles
•
Vitamin B12 injection IM 1 week prior to start + every 9 weeks until completion
•
Folic acid 400micrograms daily oral during treatment
•
Dexamethasone 4mg bd for 5 days, start day before pemetrexed
•
Stop all NSAIDS during chemotherapy
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Carboplatin / Pemetrexed
Carboplatin AUC 4/5 2
Pemetrexed 500mg/m IV
Repeat at 21 day intervals for a maximum of 6 cycles
•
Vitamin B12 injection IM 1 week prior to start + every 9 weeks until completion
•
Folic acid 400micrograms daily oral during treatment
•
Dexamethasone 4mg bd for 5 days start day before pemetrexed
•
Stop all NSAIDS during chemotherapy
Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
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Melanoma Advanced 2
Dacarbazine
850mg/m IV q 21 days max 6 cycles
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Gemcitabine + treosulphan 2
Gemcitabine 1000mg/m IV days 1 and 8 2
Treosulphan 3500mg/m IV days 1 and 8
Repeat at 28 day intervals for a maximum of 6 cycles
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply *Ipilimumab
3mg/kg IV over 90min
Repeat at 21 day intervals for 4 cycles
*NB available via the Cancer Drugs fund
*Vemurafenib
960mg bd until progression
Criteria
Tumour contains BRAF 600 mutation Unresectable or metastatic disease
*NB available via the Cancer Drugs fund
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Sarcomas Soft Tissue Sarcoma Adjuvant There is no proven role for adjuvant chemotherapy for soft tissue sarcomas. However treatment may be considered when chemo-sensitive tumours such as rhabdomyosarcoma, synovial sarcoma are resected with close margins.
Neo-adjuvant Suggested protocol for down sizing prior to surgery
Doxorubicin
20mg/m2
day 1,2,3
Mesna prior to ifosfamide
3g/m2
day 1,2,3
Ifosfamide + Mesna
3g/m2 / 3g/m2 day 1,2,3
Mesna post ifos/mesna infusion 3g/m2
day 1,2,3
Advanced There is no evidence that combinations are superior to single agents as palliative chemotherapy
First line Doxorubicin
Doxorubicin
2
75mg/m IV q 21 days x 6 cycles
Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
Second line Ifosfamide
2
Mesna prior to ifosfamide
3g/m days 1,2,3
Ifosfamide/Mesna
3g/m days 1,2,3
Mesna post ifos/mesna infusion
3g/m days 1,2,3
2 2
Repeat at 21 day intervals for up to 6 cycles Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
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Dacarbazine
2
800mg/m IV day 1
Repeat at 21 day intervals for up to 6 cycles Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
*Trabectedin Consider in select cases of advanced STS- Failure after treatment with anthracyclines and ifosfamide or intolerant/contraindications to anthracyclines and ifosfamide. Consider in Myxoid liposarcomas and leiomyosarcomas. PS 0-2 2
1.5 mg/m as IV infusion over 24 hours every 21 days.
*NB Available via the off-protocol mechanism
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Osteosarcoma / MFH of bone / Leiomyosarcoma of Bone Neoadjuvant / Post operative schedule
PAM x 2 -> Surgery (week 10) -> PAM x 2 -> Doxorubicin - Methotrexate x 2
PAM
Cisplatin
2
day 1, 2
2
days 1, 2, 3
60mg/m IV
Doxorubicin
25mg/m IV
Methotrexate
2
12g/m IV
days 22 and 29
Folinic acid rescue •
Start 24 hrs post start of Methotrexate infusion with 30mg IV 6 hourly
•
Switch to oral after 6 doses if not vomiting
•
Methotrexate levels at 24, 48, 72 hrs etc.
•
Continue until Methotrexate undetectable ie 7 prior to starting Methotrexate infusion
NB: do not give methotrexate if renal function is abnormal or in the presence of a third space. Also avoid all non-steroidal anti-inflammatory agents prior to treatment and until Methotrexate undetectable.
Doxorubicin /Methotrexate 2
Doxorubicin
37.5mg/m IV
Methotrexate
2
12g/m IV
days 1, 2 days 15 and 22
Folinic acid rescue – see above
Criteria
Age < 40yrs PS 0-2
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Cisplatin/Doxorubicin
Cisplatin
2
100mg/m IV day 1 2
2
Doxorubicin 25mg/m IV days 1, 2, 3 (20mg/m days 1-3 age > 60yrs)
Repeat at 21 days x 3 cycles then surgery then 3 further cycles.
Criteria
Not suitable for PAM schedule. PS 0-2
Laboratory investigations •
Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
•
Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
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Advanced Osteosarcoma Cisplatin/Doxorubicin
2
Cisplatin
100mg/m IV
day 1
2
Doxorubicin 25mg/m IV
days 1, 2, 3
Repeat at 21 days x 6 cycles
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • LV ejection fraction prior to cycle 1 if history of cardiac problems • FBC prior to each cycle • Normal FBC limits for administration apply
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Ewings Sarcoma Non-metastatic Ewings Sarcoma/PNET/Askin tumour / Rhabdomyosarcoma Laboratory Investigations FBC/Biochemistry/Ca/Mg/Cl/HCO3 each cycle Early morning urine PO4, Creatinine, osmolarity at baseline and repeat every other cycle of VIDE Echo/MUGA baseline/cycle 4 if indicated/cycle 6/ end Rx / pregnant Bone scan/CT chest/MRI primary/Marrow biopsy at baseline MRI primary after cycles 2, 4, 6(omit after 2 if good response) Neoadjuvant VIDE (cycles 1-6) 2
Vincristine
1.5mg/m (max 2mg) IV day 1
Doxorubicin
20mg/m IV
Mesna Etoposide Ifosfamide/Mesna Mesna
2
1g/m
days 1-3
2
day 1 2
150mg/m IV 2
days 1-3 2
1.5g/m / 1.5g/m IV 2
1.5g/m IV
Pegfilgrastim
days 1-3 days 3
6mg subcutaneous injection
day 4
Evaluation after cycle 4: •
If surgical resection likely proceed to cycles 5 and 6
•
If radiotherapy to be definitive local therapy proceed to cycles 5 and 6
•
If disease progression discontinue and consider surgery or radiotherapy
•
If pre-surgery XRT planned proceed to cycles 5 and 6 omitting doxorubicin
Dose modifications
Haematological toxicity Delayed recovery of wbc / platelets > 6 days reduce etoposide 20% Neutropenic sepsis grade 3 or 4 reduce etoposide 20% Further episodes – repeat etoposide 20% reductions
GI / Mucositis Graded 3 or 4 reduce etoposide by 20%
Cardiac function LVEF < 40% omit doxorubicin and substitute Dactinomycin1.5mg/m
2
Repeat echo after next cycle and consider reintroducing doxorubicin if LVEF has recovered.
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Definitive local treatment • Surgery should occur 21 days after cycle 6 or as soon as recovery allows. • Radiotherapy should commence concurrent with cycle 7 omitting Dactinomycin from concurrent cycles. • If radiation is required following surgery it should commence after cycle 8 omitting Dactinomycin from concurrent cycles. 2
VIA (cycles 7-14) Vincristine
1.5mg/m (max 2mg) IV 2
Dactinomycin
0.75mg/m (max 1.5mg)IV
Mesna prior to ifosfamide Ifosfamide/Mesna
1g/m
2
days 1-2 days 1-2
2
2
1.5g/m / 1.5g/m IV
Mesna post ifos/mesna infusion 1.5g/m
day 1
2
days 1-2 days 1-2
NB: omit Dactinomycin during radiotherapy
Haematological toxicity Delayed recovery of wbc/platelets > 6 days reduce Dactinomycin & Ifosfamide by 20% Neutropenic sepsis grade 3 /4 reduce Dactinomycin & Ifosfamide by 20% + add GCSF Further episodes should be managed with serial 20% reductions GI / Mucositis Grade 3 or 4 reduce Ifosfamide + Dactinomycin by 20%
Renal Toxicity GFR > 60 no change GFR 40-59 reduce Ifosfamide by 30%, reduce etoposide by 30% 2
GFR < 40 switch Ifosfamide to cyclophosphamide 1500mg/m on day 1 only reduce etoposide by 30%
Cardiac function LVEF < 40% or 10% decrease from previous level, delay chemotherapy and repeat in 7 days. If recovered proceed with chemotherapy. If still impaired consider omission or dose reduction of Ifosfamide.
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VAC
2
Vincristine
1.5mg/m IV (max 2mg)
day 1
2
Dactinomycin
0.75mg/m IV (max 1.5mg)
day 1-2
2
Mesna prior to cyclophosphamide 500mg /m IV pre –cyclophosphamide Cyclophosphamide/Mesna
2
2
1500mg/m / 1500mg/m IV
day 1 day 1
2
Mesna post cyclo/mesna infusion 1500mg/m IV post cyclophosphamide/mesna day 1
Repeat at 21 days for 4 – 6 cycles
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply
VACA (In patients unsuitable for VIDE previously NOT exposed to anthracyclines. Dactinomycin and doxorubicin on alternate cycles)
2
Vincristine
1.5mg/m IV (max 2mg)
day 1
2
Mesna prior to cyclophosphamide 500mg /m IV Cyclophosphamide/Mesna
day 1
2
2
1200mg/m / 1200mg/m IV 2
Mesna post cyclos/mesna infusion 1200mg/m IV
day 1
2
Dactinomycin
day 1
0.5mg/m IV (max 1mg)
days 1-3
Alternating with 2
Doxorubicin
20mg/m IV
days 1-3
Etopside / Ifosfamide Etoposide
120mg/m2 IV
days 1-3
Mesna prior to ifosfamide
500mg/m2
days 1-3
Ifosfamide/Mesna
3g/m2 / 3g/m2 IV
days 1-3
Mesna post ifos/mesna infusion 1.5g/m2 IV
days 1-3
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply
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Palliative Ewings Etoposide / cisplatin Etoposide
2
120mg/m IV
days 1-3
2
Cisplatin
50mg/m IV
days 1-2
AUC 5 IV
day 1
or Carboplatin
2
day1
2
days 2,3
120mg/m IV
Etoposide Etoposide
240mg/m PO
Repeat at 21 day intervals max 6 cycles
Criteria
PS 0-1 Cr cl > 50ml/min for cisplatin
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply
Cyclophosphamide/ Topotecan Relapsed Ewing’s sarcoma Relapsed/ 2
nd
line rhabdomyosarcoma
Topotecan 0.75 mg/m
2
Days 1-5
Cyclophosphamide 250 mg/m
2
Days 1-5
Cycle repeated every 21 days
Gemcitabine/Docetaxel Relapsed metastatic osteosarcoma rd
Selected metastatic soft tissue sarcomas (3 line)/ uterine leiomyosarcoma Relapsed Ewings (if other 2
Day 1
Issue Date:
nd
Gemcitabine
30th October 2012
Author: Dr. D.B. Smith
line is not suitable) 2
675 mg/m IV over 90 minutes
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Day 8
Gemcitabine
675 mg/m2 IV over 90 minutes followed by
Docetaxel
75-100mg/m2 IV over 60 minutes
Dexamethasone 8 mg bd for 3 days to start 24 hours pre docetaxel (ie Days 7-9)
Cycle repeated every 21 days
Irinotecan/Temozolomide Relapsed Ewing’s sarcoma Relapsed/ 2nd line rhabdomyosarcoma
Irinotecan 20 mg/m2 IV
Days 1-5, Days 8-12
Temozolomide 100mg/m2 po
Days 1-5
Cycle repeated every 21-28 days
Paclitaxel Angiosarcomas (2nd line or 1st line if not suitable for doxorubicin) 2
80 mg/m weekly up to 12 weeks 2
175 mg/m every 21 days (4-6 cycles, review after cycle 3)
Oral Etoposide Palliative metastatic Ewings or rhabdomyosarcoma
Etoposide 50-100mg bd 7-14 days (at clinician’s discretion)
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Aggressive fibromatosis st
1 Line Tamoxifen +/- NSAID’s nd
2
Line 2
Methotrexate 30 mg/m (usually 50mg total dose) Vinblastine
6 mg/m
2
(usually 10mg total dose)
Every 1-2 weeks Duration of course at clinician’s discretion
Vinorelbine can replace vinblastine if neuropathy is a problem.
Rhabdomyosarcoma Baseline investigations: -
FBC, U+E’s, LFT’s Bone chemistry
-
CT thorax / Abdo staging
-
Bone marrow aspirate and trephine
-
Bone Scan
-
If paramningeal site- CSF
-
Consider early morning urine for phosphate, creatinine, osmolarity for Ifosfamide containing regimes
For patients aged < 40 years: IVADo regime for high risk rhabdomyosarcoma (see separate regime)
Maintenance therapy: 2
Vinorelbine 25 mg/m IV D 1, 8, 15 2
Cyclophosphamide 25 mg/m PO OD D 1-28 Every 28 days
Maintenance therapy following IVADo to be used in:
1. For Alveolar Rhabdomyosarcoma maintenance therapy following IVADo for 6 cycles ( i.e. 6 months) 2. For metastatic disease on intensive treatment, if no residual disease or limited residual disease, IVADo to be followed by maintenance treatment for 12 cycles
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For patients > 40 years: IVAD Vincristine 1.4 mg/m2 (max dose 2mg) D1 Doxorubicin 30 mg/m2 D1, D2 2
Mesna 1.2g/m pre ifosfamide D1,D2 2
Ifosfamide 3g/m D1,D2 2
Mesna 2.4g/m post ifosfamide in 2 divided doses D1,D2
Repeat at 21 day intervals for 6 cycles
VAC Vincristine Dactinomycin
2
1.5mg/m IV (max 2mg)
Day 1
2
0.75mg/m IV (max 1.5mg)
Day 1 and 2
2
Mesna prior to cyclophosphamide 500mg /m IV pre –cyclophosphamide Cyclophosphamide/Mesna
2
Day 1
2
1500mg/m / 1500mg/m IV
Day 1
2
Mesna post cyclo/mesna infusion 1500mg/m IV post cyclophosphamide/mesna
Day 1
Repeat at 21 day intervals for 4-6 cycles
IVA Vincristine
1.5mg/m2 (max dose 2mg)
Day 1
Dactinomycin
1.5 mg/m2 (max single dose 2mg)
Day 1
Mesna prior to ifosfamide Ifosfamide/Mesna
2
1.2g/m day
Days 1-2
2
3 g/m / 3 g/m2
Days 1-2
2
Mesna post ifos/mesna infusion 2.4g/m split into 2 doses
Day 2
Repeat at 21 day intervals for 6 cycles
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IVADo Regime for High Risk Rhabdomyosarcoma Cycle 1
Cycle 3
Cycle 2
Cycle 4
Surgery/
Week
IVADo
V
V
IVADo
V
V
IVADo
1
2
3
4
5
6
7
Cycle
Cycle
5
8
15
Cycle
17
18
Cycle
8
IVA
16
Radiotherapy
10
7
IVA 14
9
Cycle
6
IVA
IVADo
9
IVA
Week
13
19
20
I=
Mesna prior to ifosfamide 1.2g/m over 1 hour
21
22
IVA 23
24
25
2
2
2
Ifosfamide/Mesna 3g/ m / 3g/m over 3 hours
Days 1-2
2
Mesna post ifos/mesna infusion 2.4g/m over 8 hours (split into 2 doses) 2
V=
Vincristine 1.5mg/m (max single dose 2mg)
A=
Dactinomycin 1.5 mg/m (max single dose 2mg)
Do=
Doxorubicin 30 mg/m
Day 1
2
Day 1
2
Days 1-2 for cycles 1-4
Each cycle: WCC>2 Neutrophils> 1.0 ( or physician’s discretion) Platelets > 80 Weekly vincristine to be given irrespective of pancytopenia unless unwell rd
nd
Reassess after cycle 3. If not CR or PR > 1/3 consider 2 line treatment + RT
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PAM Chemotherapy for Resectable Osteosarcoma
Cycle 1 AP 1
2
3
Cycle 2
M
M
AP
4
5
6
7
8
SURGERY
M
M
9
10
Cycle 3 AP
11
12
13
14
M
M
15
16
Week Cycle 4 AP 17
18
19
Cycle 5 M
M
A
20
21
22
23
Cycle 6
M
M
A
24
25
26
27
M
M
28
29
Week
AP -
Doxorubicin 25 mg/m2
Days 1-3
Cisplatin 60mg/m2
Days 1-2
M-
Methotrexate 12 g/m2 (With folinic acid rescue) Day 1
A-
Doxorubicin 37.5 mg/m
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2
Days 1-2
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Gastro-intestinal Stromal Tumours (GIST) *Adjuvant
Imatinib po 400mg daily for 36 months
Criteria
Tumour
> 5cm
Mitoses
> 5 mitoses/50 HPF
SI / colonic primary
*Available via the Cancer Drugs Fund
Imatinib (Glivec®)
Imatinib 400mg daily orally until progression
Criteria
PS 0-2
c-Kit positive locally advanced / metastatic disease
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC / biochemistry prior to each visit • Normal FBC limits for administration apply • Dose reduce if significant toxicity / rising hepatic transaminases Sunitinib (Sutent®)*
Criteria
Sunitinib
50mg orally daily for 4 weeks followed by a two week break
PS 0-2 c-Kit positive locally advanced / metastatic disease previous response to imatinib
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC / biochemistry prior to each visit • Normal FBC limits for administration apply *Available via the off protocol mechanism
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Urological Cancer Bladder Cancer - Transitional cell Neoadjuvant Cisplatin/Gemcitabine Cisplatin
2
70mg/m IV
day 1
2
Gemcitabine
1g /m IV
days 1, 8, 15
Repeat at 28 day intervals for 3 cycles prior to cystectomy
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Cisplatin / Gemcitabine split dose Cisplatin Gemcitabine
35mg/m
2
1000mg/m
2
IV days
1 and 8
IV days
1 and 8
Repeated on a 21 day schedule for up to 4 cycles
• Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply
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Author: Dr. D.B. Smith
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Concurrent Cisplatin / XRT Cisplatin/XRT
2
30-40mg/m IV weekly x 4-6 weeks as an outpatient
Cisplatin
(max 60mg) IV over 1 hour
XRT 55Gy in 20# (4 x weekly cisplatin infusions) or XRT 64Gy in 32# (6 x weekly cisplatin infusions)
Criteria
PS 0-1 Poorly differentiated TCC bladder pT2-4a, N0, M0
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply 5FU + Mitomycin C/XRT Fluorouracil
500mg/m2
days 1-5 and 16-20 of concurrent XRT
Mitomycin C
12mg/m2
day 1 of concurrent XRT
Criteria
impaired renal function
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Advanced Cisplatin/Gemcitabine 2
Cisplatin
70mg/m IV day 1
Gemcitabine
1g /m
2
IV
days 1, 8
Repeat at 21 day intervals for up to 6 cycles.
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Cisplatin / Gemcitabine split dose Cisplatin Gemcitabine
35mg/m
2
1000mg/m
2
IV days
1 and 8
IV days
1 and 8
Repeated on a 21 day schedule for up to 4 cycles • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Carboplatin/Gemcitabine Carboplatin Gemcitabine
AUC4 / 5 IV
day 1
2
1g /m IV
days 1, 8 of a 21 day cycle
For patients with impaired renal function Repeat at 21/28 day intervals for up to 6 cycles.
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Laboratory Investigation • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate or measure creatinine clearance prior to first cycle and before subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Renal cancer Advanced
First line
Interferon
Alpha Interferon
Week 1
by s/c injection:
Mon 5million units Wed 5million units Fri 10million units
Weeks 2+
Criteria
10million units Mon / Wed / Fri
PS 0-1 Relapse post nephrectomy > 12 months Low volume disease Patients should have 2 out of 3 criteria
Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
Sunitinib (Sutent®)
Sunitinib 50mg daily x 4 weeks followed by 2 week break
6 week cycles repeated until progression
Criteria
PS 0-1
Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
Pazopanib
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
Pazopanib 800mg daily Criteria
First line advanced disease No prior cytokine therapy
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Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
Sorafenib
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
Sorafenib 400mg bd orally continuously until progression
Criteria
PS 0-1 Progression on/following cytokine therapy
Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
*Temsirolimus
Temsirolimus 25mg IV weekly
Premedication
Chlorphenamine 10mg
Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
Criteria
First line therapy Poor risk patients
*NB
Only available via the Cancer Drug Fund
*Everolimus (Afinitor®) Everolimus10mg oral daily
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Laboratory Investigations •
Ensure normal renal and hepatic function prior to each cycle 1
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
Criteria
Second line therapy Biopsy proven RCC Must have had prior VEGF inhibitor
*NB
Issue Date:
30th October 2012
Author: Dr. D.B. Smith
Only available via the Cancer Drug Fund
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Prostate Cancer 2
Mitoxantrone
Mitoxantrone 12mg/m IV (max 20mg) q 21 days Maximum total dose 140mg/m
Criteria
2
Endocrine refractory disease PS 0-1 Normal FBC, renal, liver function No cardiac failure
Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
Docetaxel
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply 2
Docetaxel
75mg/m IV q21 days
Prednisolone
10mg daily until completion of chemotherapy
Dexamethasone
8mg bd x 3 days start 24hrs pre-docetaxel
Reassessment after two cycles and continue to a maximum of 10 only if responding or stable disease.
Criteria: WHO Performance Status 0-1 Hormone resistant
Laboratory Investigations • Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Abiraterone
Abiraterone 1000mg oral daily Prednisolone 10mg daily until completion of chemotherapy
Criteria
Castrate resistant Prior docetaxel chemotherapy
*Abiraterone Issue Date:
Abiraterone 1000mg oral daily
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Author: Dr. D.B. Smith
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Prednisolone 10mg daily until completion of chemotherapy
Criteria
Castrate resistant No prior chemotherapy for advanced disease PS 0-1
*Available via the Cancer Drugs Fund
*Cabazitaxel
2
Cabazitaxel
25mg/m IV infusion.
Prednisolone
10mg daily until completion of chemotherapy
premedication
Chlorphenamine 10mg Dexamethasone 16mg Ranitidine
50mg
Repeat at 21 day intervals to a maximum of 10 cycles
Criteria
nd
2 line following docetaxel PS 0-2
Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
Normal FBC limits for administration apply
*NB
Issue Date:
30th October 2012
Author: Dr. D.B. Smith
Available via the Cancer Drug Fund
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10.0
THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Germ Cell Tumours Adjuvant Stage I Pure Seminoma
Carboplatin
AUC x 7 IV - one dose only
Carboplatin
Laboratory investigations •
EDTA clearance required to calculate AUC
•
Ensure normal hepatic function prior to treatment
•
Normal FBC limits for administration apply
Stage I Non-seminomatous testicular GCT
Criteria: vascular or lymphatic invasion
BEP3
Bleomycin Etoposide Cisplatin
30000iu IV
day 1, 8, 15
2
165mg/m IV
days 1-3
2
50mg/m IV
days 1-2
Repeat at 21 day intervals for 2 cycles
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • Tumour markers: HCG,AFP,LDH where appropriate prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply Low risk – all GCT
BEP3
Bleomycin Etoposide Cisplatin
30000iu IV
day 1, 8, 15
2
165mg/m IV
days 1-3
2
50mg/m IV
days 1-2
Repeat at 21 day intervals for 3 cycles.
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Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • Tumour markers: HCG,AFP,LDH where appropriate prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply Intermediate / High risk – all GCT
BEP5
Bleomycin
30000iu IV
days 1, 5, 15
2
Etoposide
100mg/m IV
days 1-5
2
Cisplatin
cycles 1-3
20mg/m IV
days 1-5
Repeat at 21 day intervals x 3 cycles then EP5 for a further 3 cycles (i.e. omit bleomycin) Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • Tumour markers: HCG,AFP,LDH where appropriate prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply CNS disease
POMB / ACE + Intrathecal (IT) Methotrexate
POMB
Day 1
Vincristine
2mg IV
Methotrexate
1g/m IV over 24hrs (Standard dose is 300mg/m )
Folinic acid
15mg 6hrly x 12 doses start 12 hrs after completion of
Day 2
Bleomycin
15mg IV over 24hr
Day 3
Bleomycin
15mgIV over 24 hr
Day 4
Cisplatin
120mg/m IV over 12hr
2
2
Methotrexate
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Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • Tumour markers: HCG,AFP,LDH where appropriate prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply ACE
Dactinomycin
0.5mg IV
days 1-3 2
days 1-3
2
day 3
100mg/m IV
Etoposide Cyclophosphamide
500mg/m IV
Intrathecal (IT) Methotrexate
12.5mg flat dose (folinic acid rescue 15mg 6hrly x 4 start at 24hrs)
Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
Repeat cycles at 14 days from day 1, POMB, POMB, ACE, POMB, ACE etc 4-5 cycles of POMB.
Initial organ failure 2
Low dose cisplatin / etoposide
Cisplatin 20mg/m IV 2
Etoposide 100mg/m IV Repeat daily x 2-3days depending on clinical situation
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • Tumour markers: HCG,AFP,LDH where appropriate prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply
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30th October 2012
Author: Dr. D.B. Smith
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Relapsed NSGCT
TIP
2
Paclitaxel
175mg/m IV 3hr infusion day 1
Ifosfamide
1000mg/m (+mesna) IV days 1-5
Cisplatin
20mg/m IV
2
days 1-5
Premedication
Chlorphenamine
10mg IV
Dexamethasone
20mg IV
Ranitidine
50mg IV
2
Repeat at 21 day intervals x 4 cycles
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • Tumour markers: HCG,AFP,LDH where appropriate prior to each cycle • FBC prior to each cycle • Normal FBC limits for administration apply High dose chemotherapy May be curative in selected patients with drug sensitive relapsed disease.
Issue Date:
30th October 2012
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Primary CNS Malignancy Glioblastoma Multiforme – concomitant Temozolomide + XRT 2
Temozolomide
75mg/m oral daily day 1 to completion of XRT
Dose 1 hour pre-XRT and in am at weekends
Co-trimoxazole 960mg oral daily Mon / Wed / Fri until lymphocyte count normal after completing XRT
Laboratory investigations Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if
•
clinically indicated •
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC weekly
if neutrophils < 1.5 or Platelets < 100
Withhold Temozolomide until neuts > 1.5 and platelets > 100
If neutrophils < 0.5 or platelets < 10 stop Temozolomide
Criteria
Age 18 – 70 PS 0 – 1 Absence of HIV, chronic hepatitis B and hepatitis C
Adjuvant Temozolomide 2
days 1-5 cycle 1
2
days 1-5 cycle 2-6 if nadir neutrophil count > 1.5 on cycle 1
Temozolomide 150mg/m oral 200mg/m oral
Laboratory investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
•
If at any time neutrophil recovery is delayed by > 21 days treatment is discontinued
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30th October 2012
Author: Dr. D.B. Smith
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Astrocytoma
First line
Lomustine (CCNU) 40mg oral daily days 1-4 Repeat at 4-6 week intervals until progression / unacceptable toxicity
Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
Second line (1)
Temozolomide
2
Temozolomide 150mg/m oral daily for 5 days 2
Escalate to 200mg/m /day for 5 days depending on toxicity
Repeat at 28 day intervals maximum 6 cycles
Criteria: PS 0-3 Glioblastoma multiforme / anaplastic astrocytoma Prior nitrosourea Adequate marrow reserve (plts >100 neut > 1.5) No prior Temozolomide
Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
Third line options
(1)
Issue Date:
Etoposide
30th October 2012
Author: Dr. D.B. Smith
50mg oral bd for 14 days q 21-28 days
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
(2)
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply 2
Procarbazine
100-150mg/m /day oral days 1-14 repeated every 28 days
Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
Oligodendroglioma / mixed tumours
First line
PCV
Procarbazine
2
60mg/m oral 2
Lomustine (CCNU) 110mg/m oral
day 1
2
Vincristine
days 8-21
1.4mg/m (max 2mg) IV
day 8 and 29
Repeat on a 6 week schedule
Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
Second line
Consider radiotherapy
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Third line Temozolomide
2
Temozolomide 150mg/m oral daily for 5 days 2
Escalate to 200mg/m /day for 5 days depending on toxicity
Repeat at 28 day intervals maximum 6 cycles
Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
Issue Date:
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
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Author: Dr. D.B. Smith
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Primary CNS Lymphoma De Angelis
Weeks 1, 5, 9
Day -1-7 allopurinol 300mg/day
Vincristine
1.4mg/m (max 2mg) IV bolus weeks 2,
Methotrexate
3500mg/m IV over 6 hours
(Modified) 2
2
With adequate folinic acid rescue (see below) and urinary alkalinisation 2
Procarbazine
100mg/m oral daily for 7 days
Weeks 3, 7 2
Vincristine
1.4mg/m (max 2mg) IV bolus weeks 2,
Methotrexate
3500mg/m IV over 6 hours
2
With adequate folinic acid rescue (see below) and urinary alkalinisation
Dexamethasone
16mg/day week 1 12mg / day week 2 8mg/day week 3 6mg/day week 4 4mg/day week 5 2mg/day week 6
Folinic acid rescue
Issue Date:
•
Start 24 hrs post start of Methotrexate infusion with 30mg IV 6 hourly
•
Switch to oral after 6 doses if not vomiting
•
Methotrexate levels at 24, 48, 72 hrs etc.
•
Continue until Methotrexate undetectable ie 7 prior to starting Methotrexate infusion
NB: do not give methotrexate if renal function is abnormal or in the presence of a third space. Also avoid all non-steroidal anti-inflammatory agents prior to Rx and until Methotrexate undetectable.
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer methotrexate only if clearance is > 50mls/min • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply Medulloblastoma (adult) Relapse following surgery / XRT
First line PCV
Procarbazine Lomustine Vincristine
2
60mg/m oral 2
110mg/m oral
days 8-21 day 1
2
1.4mg/m (max 2mg) IV day 8 and 29
Repeat on a 6 week schedule
Laboratory investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
Second line
Temozolomide
2
Temozolomide 150mg/m oral daily for 5 days 2
Escalate to 200mg/m /day for 5 days depending on toxicity
Repeat at 28 day intervals maximum 6 cycles
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Laboratory Investigations •
Ensure normal renal and hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated
Issue Date:
•
Where renal / hepatic function are abnormal treatment is at physician discretion
•
FBC prior to each cycle
•
Normal FBC limits for administration apply
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Adenocarcinoma of Unknown Primary Origin Possible GI primary
MdG / capecitabine / gemcitabine
Possible breast primary Manage as for similar stage breast cancer
Possible ovarian primary Carboplatin 5 x (GFR+25)
Possible lung primary
Carboplatin / Gemcitabine
Midline nodal disease
+/- lung metastases
BEP3 x max 4 cycles depending on response Undifferentiated carcinoma
Etoposide / platinum 2
2
Etoposide
120mg/m days 1-3 (or oral 240mg/m )
Cisplatin
70mg/m days 1
2
Repeat at 21 day intervals max 6 cycles
Laboratory investigations • Ensure normal hepatic function prior to cycle 1 and repeat during subsequent cycles if clinically indicated • Calculate creatinine clearance prior to each cycle and administer cisplatin according to guidelines • Where renal / hepatic function are abnormal treatment is at physician discretion • FBC prior to each cycle • Normal FBC limits for administration apply
Issue Date:
30th October 2012
Author: Dr. D.B. Smith
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
CCC Emergency Chemotherapy Drugs Likely cancers requiring treatment: •
Lymphoma
•
Germ Cell Tumours
•
Small Cell Lung Cancer
Drugs Available Cisplatin
30mg in 250ml Sodium chloride 0.9% x 2 doses
Etoposide
100mg x 2 doses
Doxorubicin
50mg
Cyclophosphamide
800mg
Vincristine
2mg
Pegfilgrastim
6mg
These drugs will be stored in oncology pharmacy in the fridge in the dispensary area labelled Fridge 3. The fridge will be labelled as containing Emergency Chemotherapy Drugs. Cisplatin will be stored at room temperature on top of fridge 3.
Emergency chemotherapy should be prescribed by a consultant and entry to the pharmacy will be via the CCC bleep holder only.
Issue Date:
30th October 2012
Author: Dr. D.B. Smith
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THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Bone Metastases There is increasing evidence from studies in a number of malignancies that intravenous bisphosphonate therapy can ameliorate bone pain and reduce the risk of skeletal complications in patients with bone metastases. At present for suitable patients the recommended treatment is zelodronate + Adcal D3 until progression.
Bisphosphonates
Zoledronic acid 4mg IV in 100mls Sodium chloride 0.9% over 15-30 minutes repeated at 28 day intervals.
Criteria:
Performance status 0-2 Symptomatic / extensive bone metastases
Calcium supplements: Patients should have their serum calcium measured every four weeks and Adcal D3 prescribed as necessary.
Renal impairment:
Cr clearance
Dose of zoledronic acid
(Cockcroft-Gault) >60
4.0mg
50 - 60
3.5mg
40 - 49
3.3mg
30 –39
3.0mg
< 30
no treatment
Serum creatinine should be repeated every 4 weeks and if it rises significantly during treatment zoledronic acid should be witheld until the creatinine has returned to within 10% of the baseline prior to starting.
Ibandronate (Bondranat®) Bondranat has yet to be shown to be as effective as zoledronic acid in reducing the incidence of skeletal events and thus we cannot recommend it as routine treatment. However for patients who have difficulties with venous access or renal impairment it may be requested via the off protocol mechanism.
*Denosumab
Denosumab 120mg sc monthly Criteria
Patients ineligible for IV bisphosphonate due to poor venous access or renal impairment
*NB Available via the Cancer Drugs Fund Issue Date:
30th October 2012
Author: Dr. D.B. Smith
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CCC anti-emetic guidelines for cytotoxic chemotherapy •
Oral And IV anti-emetic formulations have equivalent efficacy
CCC Classification of chemotherapy by emetic potential (updated February 2012) LEVEL AGENT High Emetic Risk Cisplatin ≥ 50mg/m² (>90 % frequency of Cyclophosphamide > 1500mg/m² emesis) Dacarbazine Procarbazine (oral) Streptozocin AC Combination defined as either doxorubicin or epirubicin with cyclophosphamide 2 Doxorubicin >60mg/m 2 Epirubicin >90ml/m 2 Ifosfamide > 10g/m 2
Moderate Emetic Risk (30-90 % frequency of emesis)
Bendamustine Carboplatin Cisplatin < 50mg/m² Cyclophosphamide ≤1500mg/m² Cyclophosphamide (oral) Dactinomycin 2 Doxorubicin 250 mg/m² Oxaliplatin Temozolomide (oral) Vinorelbine (oral)
Low Emetic Risk (10-30 % frequency of emesis)
Cabazetaxel Capecitabine Docetaxel Doxorubicin (Liposomal) Eribulin Etoposide (IV) Evorolimus Fludarabine (oral) Fluorouracil Gemcitabine
Interferon alpha >5 50mg/m² < 250mg/m² Mitomycin Mitoxantrone Nilotinib Paclitaxel Paclitaxel-albumin (Abraxane) Pemetrexed Sunitinib Topotecan Vandetanib
Minimal Emetic Risk ( 12
no treatment required
Hb < 12
darbepoetin 150micrograms / sc weekly
If Hb rises to > 14 stop until Hb < 12 then restart at 100micrograms / week
If Hb rises by > 2g/dl / month reduce dose to 100micrograms / week
If Hb does not rise after 4 weeks treatment increase to 300micrograms / week
If no response after a further weeks then stop treatment.
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Intrathecal (IT) Chemotherapy Department of Health regulations now dictate that intra-thecal chemotherapy may only be prepared and administered by specific named individuals.
•
Prescriptions must be written on the intra-thecal prescription form
•
Patients must receive any IV chemotherapy prior to IT treatment
•
The doctor administering the IT drugs must collect them in person from pharmacy.
•
The drugs must be checked by the doctor and a qualified chemotherapy nurse prior to administration
•
All staff members involved (doctor, nurse, pharmacist) must be on the current IT chemotherapy register.
Methotrexate is the only drug we use as intrathecal therapy at a flat dose of 12.5mg.
Cytosine, thiotepa and hydrocortisone may also be given intrathecally.
All other chemotherapy drugs are potentially lethal when administered intrathecally
In addition any diluent used to prepare an intrathecal drug must be aqueous based and not alcohol based.
Intrathecal chemotherapy must always be given under the direction of a consultant and administered by one of the doctors on the CCC approved list.
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Creatinine Clearance Wright Creatinine Clearance Formula Women
((6580 – (38.8 x age)) x bsa x 0.832) /creatinine
Men
((6580 – (38.8 x age)) x bsa ) /creatinine
NB
Weight in kg Creatinine in umol/l
Calvert formula for Carboplatin dosage Carboplatin dose in mg = AUC x (Creatinine clearance + 25)
Desired area under the curve (AUC) normally 4-6 depending on protocol and clinical situation
Cisplatin dose guidelines Cisplatin is nephrotoxic and thus patients must have their renal function measured prior to each cycle.
Creatinine clearance
Cisplatin dose
> 50mls /min
100%
40 – 50 mls / min
75%
< 40mls / min
no further cisplatin
•
Patients should only commence cisplatin chemotherapy if they have an adequate performance status ie 0-2. The only exception to this is patients with advanced germ cell tumours with poor PS who may commence treatment with low dose etoposide / platinum.
•
Patients should only receive second and subsequent cycles of cisplatin if they are well and have suffered no deterioration in performance status.
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Cisplatin Hydration Policy Cisplatin doses 20 – 40mg/m2 (Outpatients) Cisplatin in 1000mL Sodium Chloride 0.9%
IV over 1 hour
Cisplatin doses 20 – 40mg/m2 (Inpatients) Prehydration
Post-hydration
Sodium Chloride 0.9% 500mL Monitor urine Output Cisplatin in 1000mL Sodium Chloride 0.9% Sodium Chloride 0.9% 500mL
IV over 1 hour IV over 1 hour IV over 1 hour
Cisplatin doses 41 - 80mg/m2 (Inpatients/Daycase)
Prehydration
Post-hydration
Furosemide Sodium Chloride 0.9% 1000mL (+ 20mmol Potassium Chloride) Monitor Urine Output Cisplatin in 1000mL Sodium Chloride 0.9% Sodium Chloride 0.9% 1000mL (+ 20mmol Potassium Chloride )
PO 20mg IV over 90 minutes
IV over 90 minutes IV over 90 minutes
Cisplatin doses >81mg/m2 (Inpatients)
Prehydration
Post-hydration
Furosemide Sodium Chloride 0.9% 1000mL (+ 20mmol Potassium Chloride) Monitor Urine Output Cisplatin in 1000mL Sodium Chloride 0.9% Sodium Chloride 0.9% 1000mL (+ 20mmol Potassium Chloride) Sodium Chloride 0.9% 1000mL
PO 20mg IV over 2 hour
IV over 4 hours IV over 4 hour IV over 4 hour
n.b. Where Urine Output is of concern, please contact a clinician for advice.
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Haematological Indices – Guidelines for the administration of chemotherapy (1) 9
administer
9
administer
Platelets > 100x10 /l + Total WBC > 3 x10 /l + 9
Neutrophils >1.0x10 /l
administer
(2) 9
Platelets 50
full dose
CrCl 30 – 49 75% dose
CrCl 60yrs
=0
< 60
=2
No
=3
Yes
=0
Systolic 90
=5
Yes
=0
No
=4
None
=5
Mild
=5
Moderate
=3
Severe
=0
Was the patient already in hospital Yes No
Score
=0 =3
17 + = low risk 1.0
>17.0
Ifosfamide 100%
40-59
0.8-0.99
14.0-16.9
Ifosfamide 70%
< 40
14.0
Switch to cyclophosphamide 1500mg/m2 IV Day 1
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Folinic acid rescue for High Dose Methotrexate Time after starting methotrexate
24 HRS
48 hrs
Methotrexate Plasma concentration in micromol/L If serum creatinine is greater that 50% of normal limit, double the folinic Acid dose Start folinic acid 15mg/m2 IV every 6 hours, then follow table below < 0.1M
0.5 – 5M
5 – 50M
Stop rescue
15mg-30mg
200mg/m
6 hourly 72 hrs
Stop rescue
15mg-30mg 6 hourly
96 hrs
Stop rescue
15mg-30mg 6 hourly
120 hrs
Stop rescue
>50M 2
6 hourly 200mg/m
2
6 hourly 200mg/m
2
6 hourly
15mg-30mg
200mg/m
6 hourly
6 hourly
2
1000mg/m
2
6 hourly 1000mg/m
2
6 hourly 1000mg/m
2
6 hourly 1000mg/m
2
6 hourly
CCC Dose Banding Policy Rationale It is widely recognised that using body surface areas (BSA) is not the most accurate method of calculating chemotherapy doses. Dose banding does not result in a significant dose variation from the traditional method as the maximum variation between the standard dose and the dose comprising each band is 5% or less. A range of pre-filled syringes may be used to administer the dose. This system has worked successfully in Cancer Centres in the UK
1, 2
.
For all intravenous chemotherapy agents there is a threshold below which it is not possible for pharmacy to guarantee the accuracy of a given dose. This usually corresponds to approximately 5% of a standard dose e.g. 10mg of Docetaxel.
Given that the calculation of chemotherapy doses on the basis of surface area is at best an educated guess, treatment is unlikely to be compromised by rounding the dose to the nearest 5% increment.
Oral agents have to be dose rounded often to a much larger tolerance e.g. Etoposide 10-16%.
Dose banding has been defined as a system whereby, through agreement between prescribers and pharmacists, doses of intravenous cytotoxics calculated on an individual basis, which are within defined Issue Date:
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ranges or bands are rounded up or down to predetermined standard doses. The initial step is to decide on the bands and how best to arrive there from the calculated dose. Taking BSA to 2 decimal place and rounding the dose to the nearest 1ml volume (taking concentration into account) appears to be the simplest way forward. All cytotoxic doses are rounded up/down, which allows easier manipulation within pharmacy.
For the following drugs the doses prescribed should be rounded or banded to the indicated pharmacy tolerance level. For drugs not on this list clinicians should round the dose to the nearest figure that approximates to 5% of the total dose.
Drugs dispensed at CCC
Dactinomycin (Actinomycin-D) Doses rounded to nearest 0.1mg dose 6
Aldesleukin (Proleukin) 18 *10 IU /1ml 6
Doses rounded to nearest 1MU (*10 ) dose
Alemtuzumab (30mg/1ml Vial) Used for TBI patients at CCC – Usual dose 10mg
Bevacizumab (400mg /16ml and 100mg / 4ml) Doses rounded to nearest 25mg dose
Bleomycin (15000 IU Vial) Usual dose either 15,000IU or 30,000IU
Liposomal Doxorubicin (Caelyx®) 20mg /10ml Liposomal Doxorubicin 45mg/m2 (Do not dose band trials)
BSA
1.3 -1.49
60mg
1.5- 1.69
70mg
1.7-1.89
80mg
>1.9
90mg
Calcium Folinate 300mg /30ml vial Folinic acid syringes for 5FU/FA regime dispensed as 50mg flat dose DeGramont type regimes dose dispensed at 350mg flat dose
Carboplatin 10mg/ 1ml (60ml Vial) Doses rounded to nearest 50mg dose Issue Date:
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Cetuximab (100mg /50ml Vial) Doses rounded to nearest 2mg dose
CMF Regimes 2
BSA (m ) < 1.39 1.40 - 1.59 1.60 -1.74 1.75 - 1.84 > 1.85
5FU Dose 800mg 900mg 1000mg 1100mg 1200mg
Methotrexate Dose 55mg 60mg 65mg 70mg 80mg
Cyclophosphamide Dose 50mg TDS14/7 50mg TDS 14/7 50mg TDS 14/7 50mg TDS 14/7 50mg QDS 14/7
If Cyclophosphamide 50mg BD 14/7 or 50mg QDS 14/7 required, Dr to specify on script.
Cisplatin (100mg /100ml) Doses rounded to nearest 10mg dose
Cyclophosphamide (1gram Vial) Doses rounded to nearest 20mg dose
Doses >800mg should be rounded to the nearest 100mg dose.
Dacarbazine (1gram Vial) Doses >1000mg should be rounded to the nearest 100mg dose.
Docetaxel (80mg Vial) 2
2
BSA (m ) 1.40 – 1.59 1.60 –1.79 1.80 – 2.00
Docetaxel Dose (100mg/m ) 150mg 170mg 190mg
Doxorubicin (200mg / 100ml Vial) Doses should be rounded to nearest 2mg dose
Doses > 80mg should be supplied in presentations corresponding to the nearest 10mg
Etoposide (500mg /25ml) Doses rounded to nearest 20mg dose
Etopophos® (Etoposide Phosphate) 100mg Vial Doses rounded to nearest 10mg dose
Epirubicin (50mg /25ml Vial) Doses > 80mg should be supplied in presentations corresponding to the nearest 10mg Issue Date:
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Epirubicin 50mg/m
2
DOSE (mg) 70 80 90 100
1.54 – 1.69 1.70 – 1.89 >1.90 Epirubicin 100mg/m
2
DOSE (mg) 1.31 –1.34 1.35 – 1.44 1.45 – 1.54 1.55 – 1.64 1.65 – 1.74 1.75 – 1.84 1.85 –1.92 >1.93
130 140 150 160 170 180 190 200
Epirubicin and Doxorubicin doses > 80mg should be dose banded to the nearest 10mg dose
Epirubicin and Doxorubicin doses < 80mg should be rounded to nearest 2mg dose
Fluorouracil (500mg / 100ml Vial)
Doses < 1000mg should be rounded to nearest 50mg dose Fluorouracil doses >1000mg should be rounded to the nearest 100mg dose.
Fluorouracil LV5 Pumps For DeGramont type regimes should be banded as below:
2400mg/m
2
BSA 1.45 – 1.51 1.52 – 1.61 1.62 – 1.71 1.72 – 1.82 1.83 – 1.92 >1.93 2800mg/m
2
BSA 1.45 – 1.47 1.48 – 1.56 1.57 – 1.65 1.66 – 1.72 1.73 – 1.86 1.87 – 2.00 Issue Date:
Dose 3500mg 3750mg 4000mg 4250mg 4500mg 4750mg
Dose 4000mg 4250mg 4500mg 4750mg 5000mg 5500mg 30th October 2012
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Fluorouracil doses at 1000mg /m
2
BSA 1.26 – 1.35 1.36 – 1.45 1.46 – 1.55 1.56 – 1.65 1.66 – 1.75 1.76 – 1.85 1.86 – 1.95 >1.96
Dose 1300mg 1400mg 1500mg 1600mg 1700mg 1800mg 1900mg 2000mg
Gemcitabine (1gram Vial) Doses dispensed to nearest 38mg dose 2
2
BSA (m ) 1.40 – 1.49 1.50 –1.69 1.70 – 1.89 1.90 – 2.00
Gemcitabine Dose (1000 mg/m ) 1400mg 1600mg 1800mg 2000mg
2
2
BSA (m )
Gemcitabine Dose (1250 mg/m )
1.40 – 1.49 1.50 –1.69 1.70 – 1.89 1.90 – 2.00
1800mg 2000mg 2300mg 2500mg
Irinotecan (100mg / 5ml) 2
2
BSA (m ) 1.40 – 1.59 1.60 –1.79 1.80 – 2.00
Irinotecan Dose (180mg/m ) 260mg 300mg 340mg
Ifosfamide (2gram Vial) Doses rounded to nearest 80mg dose
Methotrexate (500mg / 20ml) Doses rounded to nearest 5mg dose
Mesna (1000mg / 10ml) Doses rounded to nearest 100mg dose
Mitomycin (10mg Vial) Doses rounded to nearest 1mg dose
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Mitoxantrone (20mg /10 ml) Doses rounded to nearest 2mg dose
Oxaliplatin (100mg and 50mg Vial) 2
2
BSA (m ) 1.40 – 1.59 1.60 –1.79 1.80 – 2.00
Oxaliplatin Dose (85mg/m ) 130mg 150mg 170mg
Paclitaxel (300mg / 50m, 100mg / 16.7ml, 30mg / 5ml) Doses < 230mg rounded to nearest 6mg dose 2
Paclitaxel 175mg/m should be banded to the strengths below: BSA 1.30 – 1.34 1.35 – 1.42 1.43 – 1.46 1.47 – 1.62 1.63 – 1.79 1.80 – 1.94 1.94 – 2.00
Dose 230mg 240mg 250mg 270mg 300mg 330mg 350mg
Pemetrexed (500mg / 20ml) Doses rounded to nearest 50mg dose
Rituximab (100mg and 500mg Vial) Doses rounded to nearest 10mg dose
Topotecan (4mg Vial) Doses rounded to nearest 0.1mg dose
Trastuzumab (150mg Vial) Doses rounded to nearest 21mg dose Treosulfan (1gram and 5 gram Vial) Doses rounded to nearest 100mg dose
Vinblastine (10mg / 10ml Vial) Doses rounded to nearest 1mg dose
Vincristine ( 2mg / 2ml) Doses rounded to nearest 0.1mg dose
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Vindesine (5mg /5ml) Doses rounded to nearest 1mg dose
Vinorelbine (50mg / 5ml) Doses rounded to nearest 5mg dose as below
2
BSA (m ) 1.25 to 1.34 1.35 to 1.44 1.45 to 1.54 1.55 to 1.64 1.65 to 1.74 1.75 to 1.84 1.85 to 1.94 1.95
IV dose 2 25 mg/m Dose (mg) 30 30 35 40 40 45 45 50
Oral dose 2 60 mg/m Dose (mg) 80 80 90 100 100 110 110 120
IV dose 2 30 mg/m Dose (mg) 40 45 50 50 55 55 55 60
Oral dose 2 80 mg/m Dose (mg) 100 110 120 130 140 140 150 160
Oral Vinorelbine is available in 20mg and 30mg Capsules
25mg IV Vinorelbine = 60mg Oral Vinorelbine dose 30mg IV Vinorelbine = 80mg Oral Vinorelbine dose
The dose of oral Vinorelbine is approx 2.5 times that of IV Vinorelbine
References
1.
Plumridge R, Sewell G. Dose banding of cytotoxic drugs: A new concept in cancer chemotherapy. Am J Health Syst Pharm 2001; 58: 1760 –4.
2.
Baker J P, Jones S E. Rationalisation of chemotherapy services at the University Hospital Birmingham NHS Trust. J Oncol Pharm Prac 1998; 4: 10 –14.
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Surface Area Nomogram
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