Metastatic Colorectal Cancer MedDRA version: 14.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Erbitux
Product Name: Erbitux
Product Code: EMD 271 786
Pharmaceutical Form: Solution for infusion
Trade Name: Eloxatin
Sponsors
Medical Research Council
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent • Consent for screening of an archival FFPE tumour block for determination of K-ras status, with only patients with only K-raswt tumours being eligible for randomisation • Once K-raswt status confirmed, written informed consent for participation in the trial • Patients at least 18 years or over. • Confirmed colorectal adenocarcinoma: - Either previous or current histologically-confirmed primary adenocarcinoma of colon or rectum, together with clinical or radiological evidence of current advanced and / or metastatic disease. - Or histologically/cytologically-confirmed metastatic adenocarcinoma, together with clinical and/or radiological evidence of colorectal primary tumour. • Inoperable metastatic or locoregional disease. • Patients with potentially resectable liver metastases are eligible (see exclusion criteria). • Unidimensionally measurable disease (RECIST criteria, see Appendix VIII – RECIST Response Definitions). Baseline CT scan must be performed within 4 weeks prior to treatment. • No previous systemic palliative chemotherapy for metastatic disease. • Adjuvant chemotherapy with 5FU +/- FA, capecitabine or irinotecan may have been given, if completed > 1 month prior to trial entry. • Chemoradiotherapy with 5FU +/- FA or capecitabine for rectal cancer may have been given, if completed > 1 month prior to trial entry. • WHO performance status (PS) 0, 1 or 2 (see Appendix VII – WHO Performance Status) and considered by responsible consultant to be fit to undergo combination chemotherapy. • Baseline laboratory tests (within 1 week prior to randomisation): - Neutrophils = 1.5 x109/l and platelet count = 100 x109/l. - Serum bilirubin = 1.25 x upper limit of normal (ULN), alkaline phosphatase = 5 x ULN, and serum transaminase (either AST or ALT) = 2.5 x ULN. - Estimated creatinine clearance (Cockcroft and Gault; Appendix V – Cockcroft and Gault Formula) =50ml/min or measured GFR (EDTA clearance) =50 ml/min. • For women of childbearing potential, negative pregnancy test and adequate contraceptive precautions. • Effective contraception for male patients if the risk of conception exists. • Written informed consent to allow pathological material to be analysed for EGFR status, even if this is already known. 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: • Patients who have a confirmed K-ras mutation in their tumour post screening • Patients who are receiving combination chemotherapy prior to the planned resection of operable liver metastases (defined as less than 4 unilobar liver metastases, each Grade 1). • Patients requiring ongoing treatment with a contraindicated concomitant medication • Patients with another previous or current malignant disease which, in the judgement of the treating investigator, is likely to interfere with COIN-B treatment or assessment of response. • Patients with known hypersensitivity reactions to any of the components of the study treatments. • Patients with brain metastases. • Patients with a personal or family history of DPD deficiency, or with proven DPD deficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the COIN-B trial is to determine whether adding cetuximab to intermittent OxFp chemotherapy in tumours with K-raswt status, is active, safe and feasible, with the primary outcome measure of failure-free survival at 10 months.; Secondary Objective: The secondary aims are: - To assess the safety of cetuximab reintroduction with regards to frequency of Grade 3&4 allergic reactions. - To evaluate whether either arm will result in improved disease control (CR+PR+SD) at 24 weeks, overall survival, progression-free survival, response rates at 12, 24 and 36 weeks and toxicity. - Quality of life ; Primary end point(s): The primary outcome measure is to determine whether adding cetuximab to intermittent OxFp chemotherapy in tumours with K-raswt status, is active, safe and feasible, with the primary outcome measure of failure-free survival at 10 months. | — |
Countries
United Kingdom
Outcome results
None listed