Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications:

Modified Machover Colonic Cancer - Adjuvant Dose 50mg 370mg/m2 Every four weeks iv/infusion/oral iv iv q Days 1-5 Days 1-5 6

Schedule: Drug Calcium Folinate 5-Fluorouracil Cycle frequency:

Total number of cycles:

Dose modifications: Discuss with Consultant Administration and safety: Anti-emetic group Low Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L for one week Suck ice before and during 5-FU injection Calcium Folinate given first Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, mucositis, cardiotoxicity, conjunctivitis, severe diarrhoea, palmar-plantar syndrome, infertility Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals, pyridoxine cream Investigations Pre-treatment: History and Examination Performance score, weight FBC U & Es, LFTs, creatinine, urate LDH, CEA ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight FBC U & Es, LFTs, creatinine LDH, CEA Mid Treatment: Post Treatment: Reference: Re-assess after every two cycles Review in Medical Oncology Clinic 4 weeks after last cycle Quasar 2000. Lancet, 6; pages 1588-1596

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications:

Weekly QUASAR Colonic Cancer Adjuvant Dose 50mg 370mg/m2 Every week iv/infusion/oral iv iv q Day 1 Day 1 30

Schedule: Drug Calcium Folinate 5-Fluorouracil Cycle frequency:

Total number of cycles:

Dose modifications: Discuss with Consultant Administration and safety: Anti-emetic group Low Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L for one week Suck ice before and during 5-FU injection Calcium Folinate given first Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, mucositis, cardiotoxicity, conjunctivitis, severe diarrhoea, palmar-plantar syndrome, infertility Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals, pyridoxine cream Investigations Pre-treatment: History and Examination Performance score, weight FBC U & Es, LFTs, creatinine, urate LDH, CEA ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight FBC U & Es, LFTs, creatinine LDH Mid Treatment: Post Treatment: Reference: Re-assess after every 6 cycles Review in Medical Oncology Clinic 4 weeks after last cycle Quasar 2000. Lancet, 6; pages 1588-1596

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications:

Mayo Colonic Cancer - Adjuvant Dose 50mg 425mg/m2 Every four weeks iv/infusion/oral iv iv q Days 1-5 Days 1-5 6

Schedule: Drug Calcium Folinate 5-Fluorouracil Cycle frequency:

Total number of cycles:

Dose modifications: Discuss with Consultant. If toxicity experienced, or if delayed for > 1 week, reduce 5-FU dose by approximately 20% Administration and safety: Anti-emetic group Low Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L for one week Suck ice before and during 5-FU injection Calcium Folinate given first Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, mucositis, cardiotoxicity, conjunctivitis, severe diarrhoea, palmar-plantar syndrome, infertility Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals, pyridoxine cream Investigations Pre-treatment: History and Examination Performance score, weight FBC U & Es, LFTs, creatinine, urate LDH, CEA ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight FBC U & Es, LFTs, creatinine LDH Mid Treatment: Post Treatment: Reference: Re-assess after every two cycles Review in Medical Oncology Clinic 4 weeks after last cycle OConnell et al, 1997. J. Clin. Oncol., 15; pages 246-250

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications:

FLOX Colon Cancer (Adjuvant) Dose 85mg/m2 350mg 500mg/m2 Every eight weeks iv/infusion/oral 250mls 5% dex/2hrs 250mls 5% dex/2hrs iv (5 min) q Days 1, 15 & 29 Days 1,8,15,22,29,36 Days 1,8,15,22,29,36 3

Schedule: Drug Oxaliplatin Calcium Folinate 5-Fluorouracil Cycle frequency:

Total number of cycles:

Dose modifications: Discuss with Consultant Administration and safety: Anti-emetic group - Moderately high with Oxaliplatin Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L Oxaliplatin and Calcium Folinate given concurrently Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, cardiotoxicity, peripheral neuropathy, paraesthesia, severe diarrhoea, pharyngolaryngeal dysaesthesia, palmar-plantar syndrome, conjunctivitis, carcinogenesis, infertility Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals Investigations Pre-treatment: History and Examination (CNS examination) Performance score, weight FBC U & Es, LFTs, Ca2+, creatinine, urate LDH, CEA ECG Staging investigations as per protocol Prior to each cycle: CNS examination Performance score, weight FBC U & Es, LFTs, Ca2+, creatinine LDH, Post Treatment: Reference: Review in Medical Oncology Clinic 4 weeks after last cycle Wolmark et al, 2005. J. Clin. Oncol., 23(16s); abstract LBA3500

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications:

Modified de Gramont Colonic Cancer - Metastatic Dose 350mg 400mg/m2 2.8g/m2 Every two weeks iv/infusion/oral 250mls N. Saline/2hrs iv (5 mins) 4L N. Saline/46hrs q Day 1 Day 1 Days 1 & 2 up to 12

Schedule: Drug Calcium Folinate 5-Fluorouracil 5-Fluorouracil Cycle frequency:

Total number of cycles:

Dose modifications: Discuss with Consultant Administration and safety: Anti-emetic group Low Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L Suck ice before and during 5-FU bolus injection Calcium Folinate given first Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, mucositis, cardiotoxicity, severe diarrhoea, conjunctivitis, palmar-plantar syndrome, infertility Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals, pyridoxine cream Investigations Pre-treatment: History and Examination Performance score, weight FBC U & Es, LFTs, creatinine, urate LDH, CEA ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight FBC U & Es, LFTs, creatinine LDH, Mid Treatment: Post Treatment: Reference: Re-assess after every four cycles Review in Medical Oncology Clinic 4 weeks after last cycle Cheeseman et al, 2002. Br. J. Cancer, 87; pages 393-399

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications: Schedule: Drug Irinotecan

Irinotecan Colonic Cancer Palliative, Recurrent Dose 350mg/m2 Every three weeks iv/infusion/oral 250mls 5% dex/90min q Day 1 6

Cycle frequency:

Total number of cycles:

Dose modifications: Discuss with Consultant Administration and safety: Anti-emetic group Moderately high Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L Pre-medication with atropine 300 g (0.5 mls) s/c, if required Start at 250mg/ m2 if unwell, or PS=2, or aged 70 years + Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, amenorrhoea, severe diarrhoea, increased sweating and salivation, flushing, abdominal cramps, infertility Symptomatic treatment of side effects: Mouth care, Loperamide, encourage oral fluids Investigations Pre-treatment: History and Examination Performance score, weight FBC U & Es, LFTs, creatinine, urate LDH, CEA ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight FBC U & Es, LFTs, creatinine LDH, Mid Treatment: Post Treatment: Reference: Re-assess after every two cycles Review in Medical Oncology Clinic 4 weeks after last cycle Rougier et al, 1997. J. Clin. Oncol., 15; pages 251-260

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications: Schedule: Drug Oxaliplatin

Oxaliplatin Colonic Cancer - Metastatic Dose 130mg/m2 Every three weeks iv/infusion/oral 250mls 5% dex/2hrs q Day 1 6

Cycle frequency:

Total number of cycles:

Dose modifications: Discuss with Consultant Administration and safety: Anti-emetic group Moderately high Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, peripheral neuropathy, paraesthesia, diarrhoea, pharyngolaryngeal dysaesthesia, carcinogenesis, infertility Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals, Investigations Pre-treatment: History and Examination (CNS mandatory) Performance score, weight FBC U & Es, LFTs, Mg2+, Ca2+, creatinine, urate LDH, CEA ECG Staging investigations as per protocol Prior to each cycle: CNS examination Performance score, weight FBC U & Es, LFTs, Mg2+, Ca2+, creatinine LDH, Mid Treatment: Post Treatment: Reference: Re-assess after every two cycles Review in Medical Oncology Clinic 4 weeks after last cycle Ducreux et al, 2004. Ann. Oncol., 15; pages 467-473

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications:

Oxaliplatin with Modified de Gramont (FOLFOX6) Colonic Cancer - Metastatic Dose 85mg/m2 350mg 400mg/m2 2.4g/m2 Every two weeks iv/infusion/oral 250mls 5% dex/2hrs 250mls 5% dex/2hrs iv (5mins) 4L N. Saline/46hrs q Day 1 Day 1 Day 1 Days 1 & 2 up to 12

Schedule: Drug Oxaliplatin Calcium Folinate 5-Fluorouracil 5-Fluorouracil Cycle frequency:

Total number of cycles:

Dose modifications: Discuss with Consultant Administration and safety: Anti-emetic group Moderately high with Oxaliplatin Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L Oxaliplatin and Calcium Folinate given concurrently Plan Bevacizumab if appropriate Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, (alopecia), cardiotoxicity, peripheral neuropathy, paraesthesia, severe diarrhoea, pharyngolaryngeal dysaesthesia, carcinogenesis, infertility Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals Investigations Pre-treatment: History and Examination (CNS mandatory) Performance score, weight FBC U & Es, LFTs, Mg2+, Ca2+, creatinine, urate LDH, CEA ECG Staging investigations as per protocol Prior to each cycle: CNS examination Performance score, weight FBC U & Es, LFTs, Mg2+, Ca2+, creatinine LDH, Mid Treatment: Post Treatment: Reference: Restage after 6 cycles Review in Medical Oncology Clinic 4 weeks after last cycle Cheeseman et al, 2002. Br. J. Cancer, 87; pages 393-399

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications:

Irinotecan with Modified de Gramont (FOLFIRI) Colonic Cancer - Metastatic Dose 180mg/m2 350mg 400mg/m2 2.4g/m2 Every two weeks iv/infusion/oral 250mls 5% dex/30mins 250mls N. Saline/2hrs iv (5mins) 4L N. Saline/46hrs q Day 1 Day 1 Day 1 Days 1 & 2 up to 12

Schedule: Drug Irinotecan Calcium Folinate 5-Fluorouracil 5-Fluorouracil Cycle frequency:

Total number of cycles:

Dose modifications: Discuss with Consultant Administration and safety: Anti-emetic group Moderately high with Irinotecan Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L Pre-medication with atropine 300g (0.5mls) s/c may be required Suck ice before and during 5-FU bolus injection Plan Bevacizumab if appropriate Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, cardiotoxicity, severe diarrhoea, amenorrhoea, increased sweating and salivation, flushing, abdominal cramps, infertility Symptomatic treatment of side effects: Prophylactic mouth care, Loperamide, encourage oral fluids Investigations Pre-treatment: History and Examination (CNS mandatory) Performance score, weight FBC U & Es, LFTs, creatinine, urate LDH, CEA ECG Staging investigations as per protocol Prior to each cycle: CNS examination Performance score, weight FBC U & Es, LFTs, creatinine LDH, Mid Treatment; Post Treatment: Reference: Restage after 6 cycles Review in Medical Oncology Clinic 4 weeks after last cycle Tournigand et al, 2004. J. Clin. Oncol., 22 ; pages 229-237

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications: Schedule: Drug Capecitabine

Capecitabine Colonic Cancer Adjuvant or Metastatic Dose 1250mg/m2 bd Every three weeks iv/infusion/oral oral q Days 1-14 8 (if adjuvant)

Cycle frequency:

Total number of cycles:

Dose modifications: Discuss with Consultant Administration and safety: Anti-emetic group Low Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L Ensure patient education regarding palmar-plantar syndrome Round Capecitabine tablets to the nearest 150mg or 500mg (see data sheet) Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, hair thinning, amenorrhoea, diarrhoea, skin rash, palmar-plantar syndrome, infertility. Symptomatic treatment of side effects: Mouth care Investigations Pre-treatment: History and Examination Performance score, weight FBC U & Es, LFTs, creatinine, urate LDH ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight FBC U & Es, LFTs, creatinine LDH Mid Treatment: Post Treatment: Reference: Re-assess after every two cycles Review in Medical Oncology outpatients 4 weeks after last cycle Van Cutsem et al, 2000. J. Clin. Oncol., 18; pages 1337-1345

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications: Schedule: Drug Irinotecan Capecitabine

Irinotecan/Capecitabine (XELIRI) Colonic Cancer Metastatic Dose 240mg/m2 1000mg/m2 bd Every three weeks iv/infusion/oral 250mls 5% dex/30min oral q Day 1 Days 1-14 6 -12

Cycle frequency:

Total number of cycles:

Dose modifications: Discuss with Consultant Administration and safety: Anti-emetic group - Moderately high with Irinotecan Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L Pre-medication with atropine 300ug (0.5mls) s/c may be required Ensure patient education regarding palmar-plantar syndrome Round Capecitabine dose to nearest 500mg or 150mg (see data sheet) Plan Bevacizumab if appropriate Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, amenorrhoea, peripheral neuropathy, severe diarrhoea, increased sweating and salivation, flushing, hypersensitivity reactions, skin rash, cardiotoxicity, palmar-plantar syndrome, fluid retention, hepatic dysfunction, infertility Symptomatic treatment of side effects: Mouth care Investigations Pre-treatment: History and Examination Performance score, weight FBC U & Es, LFTs, creatinine, urate LDH ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight FBC U & Es, LFTs, creatinine LDH Mid Treatment: Post Treatment: Reference: Re-assess after every two cycles Review in Medical Oncology outpatients 4 weeks after last cycle Park et al, 2004. Oncology, 66; pages 353-357

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications: Schedule: Drug Oxaliplatin Capecitabine

Oxaliplatin/Capecitabine (XELOX) Colonic Cancer Metastatic Dose 130mg/m2 1000mg/m2 bd Every three weeks iv/infusion/oral 250mls 5% dex/2hrs oral q Day 1 Days 1-14 6 -12

Cycle frequency:

Total number of cycles:

Dose modifications: Discuss with Consultant Administration and safety: Anti-emetic group - Moderately high with Oxaliplatin Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L Ensure patient education regarding palmar-plantar syndrome Round Capecitabine dose to nearest 500mg or 150mg (see data sheet) Plan Bevacizumab if appropriate Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, amenorrhoea, peripheral neuropathy, severe diarrhoea, paraesthesia, pharyngolaryngeal dysaesthesia,, hypersensitivity reactions, skin rash, cardiotoxicity, palmar-plantar syndrome, hepatic dysfunction, infertility Symptomatic treatment of side effects: Mouth care Investigations Pre-treatment: History and Examination Performance score, weight FBC U & Es, LFTs, creatinine, urate LDH ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight FBC U & Es, LFTs, creatinine LDH Mid Treatment: Post Treatment: Reference: Re-assess after every two cycles Review in Medical Oncology outpatients 4 weeks after last cycle Cassidy et al, 2004. Clin. Oncol., 22; pages 2084-2091

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indication: Schedule: Drug Cetuximab Cetuximab

Cetuximab (Erbitux) Colorectal cancer - metastatic Dose 400mg/m2 250mg/m2 Every week Discuss with Consultant iv/infusion/oral iv (2hrs) as per datasheet iv (1hr) as per datasheet q Day 1 weekly Indefinite

Cycle frequency: Dose modification:

Total number of cycles:

Administration and safety: Anti-emetic group Low Delay if neutrophils < 1.0 x 109/L or platelets < 100 x 109/L Pre-med with Chlorpheniramine With Irinotecan (180 350mg/m2 ) every three weeks Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, hyper-sensitivity reaction, carcinogenesis, infertility, allergic-like reaction, bronchospasm, hypotension, chills/fevers, rigors, skin rash, asthenia, stomatitis, anorexia, constipation, acne Symptomatic treatment of side effects: Supportive therapy Investigations Pre-treatment: History and Examination Performance score, weight FBC U & Es, LFTs, creatinine, urate LDH ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight FBC U & Es, LFTs, creatinine LDH Post Treatment: Reference: Review in Medical Oncology Clinic 4 weeks after last cycle Cunningham et al, 2004. N. Engl. J. Med., 351; pages 337-345

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indication: Schedule: Drug Bevacizumab

Bevacizumab (Avastin) Colorectal cancer - metastatic Dose 5mg/kg Every 2 weeks iv/infusion/oral 100mls N. Saline (as below) q each cycle Indefinite

Cycle frequency: OR Drug Bevacizumab Cycle frequency: Dose modification:

Total number of cycles:

Dose 7.5mg/kg Every 3 weeks

in/infusion/oral 100mls N. Saline (as below)

q each cycle Indefinite

Total number of cycles:

Discuss with Consultant

Administration and safety: Anti-emetic group Low Delay if neutrophils < 1.0 x 109/L or platelets < 100 x 109/L 1st infusion 90mins; 2nd infusion 60mins; 3rd infusion 30mins If the patient is a candidate for surgery, administer 4 cycles only Toxicities: Hypersensitivity reaction, allergic-like reaction, hypertension, skin rash, proteinuria, thromboembolism, impaired wound healing, GI perforation Symptomatic treatment of side effects: Supportive therapy Investigations Pre-treatment: History and Examination Performance score, weight, blood pressure, proteinuria FBC U & Es, LFTs, creatinine, urate LDH ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight, blood pressure, proteinuria FBC U & Es, LFTs, creatinine LDH Post Treatment: Reference: Review in Medical Oncology Clinic 4 weeks after last cycle Hurwitz et al, 2004. N. Engl. J. Med., 350; pages 2335-2342 Miller et al, 2005. J. Clin. Oncol., 23; pages 792-799

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indication:

Modified OConnell (5-Fluorouracil/RT) Rectal Cancer Adjuvant Dose 425mg/m2 45Gy 225mg/m2/24hrs Every four weeks iv/infusion/oral iv 5 weeks continuous infusion q Days 1-5 Start day 56 for 5 weeks 4

Schedule: Drug 5-Fluorouracil Radiotherapy With 5-Fluorouracil Cycle frequency: Dose modification:

Total number of cycles:

Discuss with Consultant. If toxicity experienced, or if delayed for > 1 weeks, reduce 5-FU dose by 20%

Administration and safety: Anti-emetic group Low Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L for one week Suck ice before and during 5-FU injection Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, mucositis, cardiotoxicity, conjunctivitis, severe diarrhoea, palmar-plantar syndrome, infertility Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals, pyridoxine cream Investigations Pre-treatment History and Examination Performance score, weight FBC U & Es, LFTs, creatinine, urate LDH, CEA ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight FBC U & Es, LFTs, creatinine LDH, Mid Treatment: Post Treatment: Reference: Re-assess after every two cycles Review in Medical Oncology Clinic 4 weeks after last cycle OConnell et al, 1994, N. Engl. J. Med., 331; pages 502-507

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications: Schedule: Drug Epirubicin Cisplatin 5-Fluorouracil

ECF (Epirubicin/Cisplatin/5-Fluorouracil) Oesophageal/Gastric Neoadjuvant, Metastatic, Locally advanced Dose 50mg/m2 60mg/m2 200mg/m2/24hrs Every three weeks in/infusion/oral iv 1L N. Saline/2hrs continuous infusion q Day 1 Day 1 Days 1-21 6

Cycle frequency:

Total number of cycles:

Dose modifications: Discuss with Consultant Administration and safety: Anti-emetic group High Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L Ensure adequate renal function Hickman line required Pre & post hydration, mannitol, potassium & magnesium Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, Cardiotoxicity, peripheral neuropathy, palmar-plantar syndrome, Nephrotoxicity, diarrhoea, carcinogenesis, infertility Symptomatic treatment of side effects: Mouth care, anti-diarrhoeals, pyridoxine Investigations Pre-treatment: History and Examination Performance score, weight FBC U & Es, LFTs, Mg2+, Ca2+, creatinine, urate, creatinine clearance LDH ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight FBC U & Es, LFTs, Mg2+, Ca2+, creatinine LDH Mid Treatment: Post Treatment: Reference: Re-assess after 3 cycles (endoscopy +/- radiology) Review in Medical Oncology Clinic 4 weeks after last cycle Findlay et al, 1994. Ann, Oncol., 5; pages 609-616

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications: Schedule: Drug Cisplatin 5-Fluorouracil

CF (Cisplatin/5-Fluorouracil) Oesophageal Neoadjuvant Dose 75mg/m2 1g/m2/24 hrs Every three weeks iv/infusion/oral 1L N. Saline/2hrs continuous infusion q Day 1 Days 1-4 2

Cycle frequency:

Total number of cycles: (neoadjuvant)

Dose modifications: Discuss with Consultant Administration and safety: Anti-emetic group High Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L Ensure adequate renal function Pre & post hydration, mannitol, potassium & magnesium Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, cardiotoxicity, peripheral neuropathy, palmar-plantar syndrome, nephrotoxicity, ototoxicity, diarrhoea, carcinogenesis, infertility Symptomatic treatment of side effects: Mouth care, anti-diarrhoeals, pyridoxine Investigations Pre-treatment: History and Examination Performance score, weight FBC U & Es, LFTs, Mg2+, Ca2+, creatinine, urate, creatinine clearance LDH ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight FBC U & Es, LFTs, Mg2+, Ca2+, creatinine LDH Mid Treatment: Post Treatment: Reference: Re-assess after 2 cycles (endoscopy +/- radiology) Review in Medical Oncology Clinic 3 weeks after last cycle MRC Oesophageal Cancer WP, 2002. Lancet, 359; pages 1727-1733

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indication: Schedule: Drug Cisplatin 5-Fluorouracil Radiotherapy

Herskovic (Cisplatin/5-Fluorouracil/RT) Oesophageal Locally advanced (inoperable) Dose 75mg/m2 1g/m2/24hrs 50Gy Every four weeks iv/infusion/oral 1L N. Saline/2hrs continuous infusion 5 weeks q Day 1 Days 1-4 Start Day 1 4

Cycle frequency:

Total number of cycles: (First 2 cycles with RT)

Dose modifications: Discuss with Consultant Administration and safety: Anti-emetic group High Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L Ensure adequate renal function Pre & post hydration, mannitol, potassium & magnesium Concurrent radiotherapy may be necessary Doses may change according to radiotherapy schedule Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea & vomiting, mucositis, alopecia, cardiotoxicity, peripheral neuropathy, palmar-plantar syndrome, nephrotoxicity, ototoxicity, diarrhoea, carcinogenesis, infertility Symptomatic treatment of side effects: Mouth care, anti-diarrhoeals, pyridoxine Investigations Pre-treatment History and Examination Performance score, weight FBC U & Es, LFTs, Mg2+, Ca2+, creatinine, urate, creatinine clearance LDH ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight FBC U & Es, LFTs, Mg2+, Ca2+, creatinine LDH Mid Treatment: Post Treatment: Reference: Review in Medical Oncology post-radiotherapy Review in Medical Oncology Clinic 4 weeks after last cycle Herskovic et al, 1992, N. Engl. J. Med., 326; pages 1593-1598

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications:

MMC with Modified de Gramont Gastric Cancer Advanced Dose 6mg/m2 350mg 400mg/m2 2.4g/m2 Every three weeks iv/infusion/oral iv 250mls N. Saline/2hrs iv (5mins) 4L N. Saline/46hrs q Day 1 Day 1 Day 1 Days 1 & 2 4

Schedule: Drug Mitomycin C Calcium Folinate 5-Fluorouracil 5-Fluorouracil Cycle frequency:

Total number of cycles:

Dose modifications: Discuss with Consultant Administration and safety: Anti-emetic group Moderate Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L Suck ice before and during 5-Fluorouracil bolus injection Ensure serum creatinine is within normal levels Blood film is normal i.e. no red cell fragmentation Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, mucositis, cardiotoxicity, severe diarrhoea, infertility, conjunctivitis, palmar-plantar syndrome Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrhoeals, pyridoxine cream Investigations Pre-treatment: History and Examination Performance score, weight FBC U & Es, LFTs, creatinine, urate LDH ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight FBC U & Es, LFTs, creatinine LDH Blood film Mid Treatment: Post Treatment: Reference: Re-assess after every two cycles Review in Medical Oncology Clinic 4 weeks after last cycle. Ross et al, 1997, Ann Oncol., 8; pages 995-1001

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications:

Modified MacDonald (5-Fluorouracil/FA/RT) Gastric Cancer Adjuvant Dose 40mg/m2 425mg/m2 45Gy 20mg/m2 400mg/m2 Every four weeks iv/infusion/oral iv iv 5 weeks iv iv q Days 1-5 Days 1-5 Start day 29 First 4 & last 3 days of RT First 4 & last 3 days of RT 3

Schedule: Drug Calcium Folinate 5-Fluorouracil Radiotherapy Calcium Folinate 5-Fluorouracil Cycle frequency:

Total number of cycles: (1 cycle prior to RT)

Dose modifications: Discuss with Consultant. If toxicity experienced, or if delayed for > 1 week, reduce 5-FU dose by 20% Administration and safety: Anti-emetic group Low Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L for one week Suck ice before and during 5-FU injection Calcium Folinate given first Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, mucositis, cardiotoxicity, conjunctivitis, severe diarrhoea, palmar-plantar syndrome, infertility Symptomatic treatment of side effects: Prophylactic mouth care, anti-diarrheals, pyridoxine cream Investigations Pre-treatment History and Examination Performance score, weight FBC U & Es, LFTs, creatinine, urate LDH, ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight FBC U & Es, LFTs, creatinine LDH, Post Treatment: Reference: Review in Medical Oncology Clinic 4 weeks after last cycle Macdonald et al, 2001. N. Engl. J. Med., 345; pages 725-730

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Department of Medical Oncology

Chemotherapy Protocols

Protocol: Indications: Schedule: Drug Gemcitabine

Gemcitabine Pancreatic Cancer Palliative Dose 1000mg/m2 Every four weeks iv/infusion/oral 200mls N. Saline/30mins q Days 1, 8 &15 6

Cycle frequency:

Total number of cycles:

Dose modifications: Discuss with Consultant Administration and safety: Anti-emetic group - Moderate Delay if neutrophils < 1.5 x 109/L or platelets < 100 x 109/L If unable to tolerate, omit day 15 and give every 3 weeks Toxicities: Myelosuppression and risk of neutropenic sepsis or haemorrhage, nausea, mucositis, amenorrhoea, rash, flu-like symptoms, hair thinning, diarrhoea, infertility Symptomatic treatment of side effects: Mouth care Investigations Pre-treatment: History and Examination Performance score, weight FBC U & Es, LFTs, creatinine, urate LDH, CA19-9 ECG Staging investigations as per protocol Prior to each cycle: Performance score, weight FBC U & Es, LFTs, creatinine LDH, CA19-9 Mid Treatment: Post Treatment: Reference: After every two cycles Review in Medical Oncology Clinic 4 weeks after last cycle Burris et al, 1997. J. Clin. Oncol., 15; pages 2403-2413

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