WEEKLY SINGLE AGENT
Cumbria, Northumberland, Tyne & Wear Area Team
DRUG ADMINISTRATION SCHEDULE
Day
Drug
Daily Dose
Days 1,
8, 15 &
22
Route
Subcutaneous
Bolus
Atropine*
0.25mg
Sodium Chloride
0.9%
250/500ml
Infusion
Dexamethasone
8mg
IV bolus
Ondansetron
8mg
Irinotecan
125 mg/ m2
Diluent
Rate
Fast Running
Via saline
drip
Oral /Slow bolus/15 min infusion
IV Infusion
250mls NaCl
0.9%
90mins
*Ondansetron IV must be infused over 15 minutes in patients over 65 years of age.
CYCLE LENGTH AND NUMBER OF DAYS
6 week cycle drugs given every 7 days for 4 weeks, then 2 weeks off
APPROVED INDICATIONS
Second line therapy for advanced/ metastatic colorectal cancer for patients who are
unsuitable for standard combination therapy or 3 weekly irinotecan
ELIGIABILITY CRITERIA
Metastatic large bowel cancer that can be considered for irinotecan
chemotherapy but may not tolerate the 3-weekly regimen.
ECOG performance status 0 – 2 if age less than 65 years and 0 – 1 if older
EXCLUSION CRITERIA
Bilirubin ≥ 3 x ULN and / or other liver enzymes ≥ 5 x ULN
Uncontrolled diarrhoea of more than Grade I prior to start of treatment
PREMEDICATION
*If acute cholinergic syndrome appears atropine sulphate should be administered
unless clinically contraindicated. The manufacturer recommends the use of
prophylactic atropine sulphate with subsequent doses of Irinotecan.
RECOMMENDED TAKE HOME MEDICATION
Ondansetron 8mg twice daily for 2 to 3 days
Dexamethasone 4mg twice daily for 1 to 3 days
Metoclopramide 10mg three times daily as required.
Loperamide as required (4mg after first loose stool and 2mgs every 2 hours, to a
maximum of 16 (2mg) tablets in 24 hours.
INVESTIGATIONS / MONITORING REQUIRED
Blood Pressure ½ hourly during treatment and ½ hour post treatment.
FBC, U&E’s, LFT’s, tumour markers as appropriate and hepatobillary function prior to
each cycle
FBC on the day of chemotherapy
CR002-Weekly-Irinotecan-CNTW-protocol-CRP09-CR002 v1.3
Issue Date 29/05/2014
Page 1 of 3
Expiry Date May 2016
WEEKLY SINGLE AGENT
Cumbria, Northumberland, Tyne & Wear Area Team
ASSESSMENT OF RESPONSE
As indicated clinically. Patients should undergo formal objective response
assessment no later than every three cycles.
REVIEW BY CLINICIAN
Patients are to be reviewed by their clinician or their deputy at least once every six
weeks.
NURSE / PHARMACIST LED REVIEW
Prior to each Dose.
ADMINISTRATION NOTES
Patients must be made aware of the risk of delayed diarrhoea occurring 24 hours after
the administration of Irinotecan and at any time before the next cycle. This means
supplying information sheets to the patient and if appropriate to their GP.
Early onset diarrhoea (within the first 24 hours) can be a result of acute
cholinergic syndrome and may occur in 9% of patients. Symptoms are short
lasting and respond within minutes to administration of atropine (0.25-1mg
subcutaneously).
Delayed diarrhoea must be treated immediately with high dose Loperamide (4mg after
first loose stool and 2mgs every 2 hours, to a maximum of 16 (2mg) tablets in 24
hours. Hospitalise if condition not resolved in 48 hours.
For diarrhoea lasting greater than 24 hours add ciprofloxacin 250mg BD. Note
many units give patient a supply of loperamide and ciprofloxacin at the start of
treatment.
Due to the greater frequency of decreased biological functions, in particular
hepatic function, in elderly patients, dose selection with irinotecan should be
cautious in this population. Refer to oncologist for age >70 and performance
status >=2.
EXTRAVASATION See NECN / local Policy
TOXICITIES
Acute cholinergic syndrome (defined as early diarrhoea and various other
symptoms such as sweating, abdominal cramping, lacrimation, myosis and
salivation)
Diarrhoea –Risk of severe delayed diarrhoea – can be life threatening
Myelosuppression
Alopecia
Dizziness during treatment
Anaphylaxis
CR002-Weekly-Irinotecan-CNTW-protocol-CRP09-CR002 v1.3
Issue Date 29/05/2014
Page 2 of 3
Expiry Date May 2016
WEEKLY SINGLE AGENT
Cumbria, Northumberland, Tyne & Wear Area Team
DOSE MODIFICATION / TREATMENT DELAYS
Haematological toxicity:
Delay treatment until ANC ≥ 1.5, platelets ≥ 100
If delay ≥ 2 weeks, dose reduce by 20% and continue at this dose unless further
toxicity occurs.
If ANC < 0.5 or febrile neutropenia or neutropenic infection occurs during course
of treatment, dose reduce by 20%
Non-haematological toxicity:
Diarrhoea grade 2 during course of treatment → delay until recovered and give
full dose
Diarrhoea grade 3/ 4 during a course of treatment, delay until recovered and
resume treatment at 20% reduced dose of Irinotecan
Hepatic, bilirubin rising consider 50% dose reduction.
Omit if bilirubin 3 x ULN
Renal rising creatinine and GFR < 30mls/min, consider 50% dose reduction
Note toxicity can be unpredictable & severe.
TREATMENT LOCATION
Cancer Centre or Cancer Unit
REFERENCES:
Devita Cancer: Principles & Practice of Oncology) Chapter 29 - Cancers of the
Gastrointestinal Tract > SECTION 8: Cancer of the Colon > MANAGEMENT OF
UNRESECTABLE METASTATIC DISEASE > IRINOTECAN 7th Edition 2005
Pfizer. Summary of Product Characteristics – Campto. 02 March 2007.
Rothenberg et al. A Multicenter, Phase II Trial of Weekly Irinotecan (CPT-11) in
Patients with Previously Treated Colorectal Carcinoma CANCER February 15,
1999 / Volume 85 / Number 4
Document Control
Document Title:
Weekly Irinotecan CNTW protocol CRP09 CR002
Document No:
CRP09 CR002
Author:
Approved by:
Current
Version:
Steve Williamson
Consultant Pharmacist
Ashraf Azzabi
Associate Specialist Oncology/
Honorary Clinical Lecturer and Deputy
Degree Program Director NCCT
1.3
Approval
Signature*
Date
Approved:
29.05.14
Due for Review:
May 2016
Summary of
Changes
1.1
Document control numbering updated
1.2
Protocol reviewed
1.3
Protocol reviewed and reissued, Antiemetic advice updated
CR002-Weekly-Irinotecan-CNTW-protocol-CRP09-CR002 v1.3
Issue Date 29/05/2014
Page 3 of 3
Expiry Date May 2016