metastatic or locally advanced colorectal cancer MedDRA version: 9.1 Level: LLT Classification code 10052362 Term: metastatic colorectal cancer
Conditions
Interventions
Product Name: irinotecan
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: irinotecan
CAS Number: 97682-44-5
Current Sponsor code: n/a
Other descriptive name: n/a
Concent
Sponsors
Medical Research Council
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient inclusion criteria 1. Male/Female patients at least 18 years or over. 2. Confirmed colorectal adenocarcinoma: - Either previous or current histologically confirmed primary adenocarcinoma of colon or rectum, together with clinical or radiological evidence of locally advanced disease or metastatic disease or both - Or histologically confirmed metastatic adenocarcinoma, together with clinical and/or radiological evidence of colorectal primary tumour 3. Inoperable metastatic or locoregional disease 4. Unidimensionally measurable disease. Baseline CT scan must be performed within 4 weeks prior to treatment 5. Adjuvant chemotherapy with 5FU +/- FA, capecitabine or oxaliplatin combinations may have been given, if chemotherapy completed at least 6 months prior to trial entry. QUASAR 2 patients who have continued bevacizumab for 6 months following completion of chemotherapy are eligible immediately following completion of bevacizumab (Avastin). 6. Rectal chemoradiotherapy with 5FU +/- FA or capecitabine may have been given, if completed at least 1 month prior to trial entry 7. Fit to receive any of the treatment regimens proposed as defined by: - WHO performance status (PS) 0, 1 or 2 and considered by responsible consultant to be fit to undergo combination chemotherapy. - Baseline laboratory tests (within 1 week prior to randomisation normally): Neutrophils =1.5 x109/l and platelet count =100 x109/l Alkaline phosphatase =5 x upper limit of normal (ULN), Serum bilirubin =1.25 x ULN, and serum transaminase (either AST or ALT) =2.5 x ULN Estimated creatinine clearance =30ml/min or measured GFR (EDTA clearance) =30 ml/min 8. For women of childbearing potential, negative pregnancy test and adequate contraceptive precautions 9. Effective contraception for male patients if the risk of conception exists 10. Written informed consent including consent to the immediate release of tumour blocks for analysis of molecular markers Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients expected to be suitable for surgical resection of metastatic disease after response to chemotherapy as decided by MDT. (These patients should be considered for the New-EPOC trial) 2. No previous systemic chemotherapy for metastatic disease 3. Pregnant or lactating women 4. Inability to attend or comply with treatment or follow-up scheduling 5. Patients who are unfit for the chemotherapy regimens in this protocol, e.g.: - Severe uncontrolled concurrent medical illness (including poorly controlled angina, uncontrolled hypertension or very recent Myocardial Infarction (MI), (i.e. in previous 3 months) likely to interfere with protocol treatments. - History of severe peptic ulcer disease - Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or to comply with oral medication. - Nephrotic Syndrome - Known coagulopathy - Patients requiring ongoing therapy with ciclosporin-A (due to interaction with irinotecan) 6. Patients requiring ongoing treatment with a contraindicated concomitant medication 7. Patients with another previous or current malignant disease which, in the judgement of the treating investigator, is likely to interfere with FOCUS 3 treatment or assessment of response 8. Patients with known hypersensitivity reactions to any of the components of the study treatments 9. Patients with brain metastases 10. Patients with a personal or family history suggestive of DPD deficiency or with known DPD deficiency 11. History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent 12. History of surgery <4weeks prior to commencement of cycle 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research questions are: 1) Of those patients randomised, in how many patients was the interval between registration to the trial and the provision of results to the investigator to allow randomisation less than or equal to 10 working days 2) Of those patients randomised, in how many patients was the interval between registration and the date of randomisation less than or equal to 10 working days ;Secondary Objective: The secondary endpoints of the trial are: 1) Time from date of requesting hospital pathology laboratory to release a tumour sample to date of receipt of sample at central laboratory (Leeds or Cardiff) 2) Of those patients registered but not subsequently randomised, for what reasons did randomisation not occur (insufficient sample material, technical failure, unacceptable delay, patient refusal, patient ineligibility) 3) Time from registration consent to start of treatment 4) In all randomised patients, time from the provision of data to the investigator to allow randomisation to the date of randomisation. 5) Reproducibility of K-ras mutation and topo-1 results between laboratory centres and methodological problems identified 6) Distribution frequencies of topo-1 expression and K-ras mutation analysis and the distribution of patients between sub-groups to inform power calculations for the main study 7) Costs of the molecular testing 8) Toxicity, response rates and prog;Primary end point(s): 1) Of those patients randomised, in how many patients was the interval between registration and the provision of results to the investigator to allow randomisation less than or equal to 10 working days. 2) Of those patients randomised, in how many patients was the interval between registration and the date of randomisation less than or equal to 10 working days. | — |
Countries
United Kingdom
Outcome results
None listed