A Phase III trial comparing either COntinuous chemotherapy plus cetuximab or INtermittent chemotherapy with standard continuous palliative combination chemotherapy with oxaliplatin and a fluoropyrimidine in first line treatment of metastatic colorectal cancer

Phase 3

Completed

• Conditions: Metastatic colorectal cancer; Cancer; Colorectal

• Registration Number: ISRCTN27286448
• Lead Sponsor: Medical Research Council (UK)

Brief Summary

1. 2008 review in http://www.ncbi.nlm.nih.gov/pubmed/18699762 2. 2009 toxicity results in http://www.ncbi.nlm.nih.gov/pubmed/19165196 3. 2011 phase 3 results in http://www.ncbi.nlm.nih.gov/pubmed/21641636 4. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22935584

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-10-22
• Study Completion: 2005-08-01
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2421

Inclusion Criteria

1. Confirmed colorectal adenocarcinoma:
- either previous or current histologically confirmed primary adenocarcinoma of colon or rectum, together with clinical or radiological evidence of advanced and/or metastatic disease
- or histologically/cytologically confirmed metastatic adenocarcinoma, together with clinical and/or radiological evidence of colorectal primary tumour
2. Inoperable metastatic or locoregional disease. Patients who are currently eligible for combination first-line chemotherapy prior to liver resection under National Institute for Clinical Excellence (NICE) guidance are ineligible for this study.
3. Unidimensionally measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST])
4. No previous systemic palliative chemotherapy for metastatic disease
5. Adjuvant chemotherapy with 5-Fluorouracil (5FU) +/- folinic acid (FA), Capecitabine or irinotecan may have been given, if completed >6 months prior to trial entry
6. Rectal chemoradiotherapy with 5FU +/- FA may have been given, if completed >1 month prior to trial entry
7. World Health Organistion (WHO) performance status (PS) 0, 1 or 2 and considered by responsible consultant to be fit to undergo combination chemotherapy
8. Baseline laboratory tests (within 1 week prior to randomisation):
White blood cell count (WBC) =4 x 10^9/l, neutrophils =1.5 x 10^9/l and platelet count >150 x 10^9/l.
Serum bilirubin =1.25 x upper limit of normal (ULN), alkaline phosphatase =5 x ULN, and serum transaminase (either aspartate transaminase [AST] or alanine transaminase [ALT]) =3 x ULN.
Estimated creatinine clearance >50 ml/min or measured glomerular filtration rate (GFR) (ethylene diamine tetraacetic acid [EDTA] clearance) >50 ml/min.
9. For women of childbearing potential, negative pregnancy test and adequate contraceptive precautions
10. Consent to allow surplus pathological material to be analysed for epidermal growth factor receptor (EGFR) testing

Exclusion Criteria

1. Patients who are unfit for the chemotherapy regimens in this protocol e.g.
Severe uncontrolled concurrent medical illness (including poorly-controlled angina or very recent myocardial infarction [MI], i.e. in previous 3 months) likely to interfere with protocol treatments
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
Partial or complete bowel obstruction
Pre-existing neuropathy (>grade 1)
2. Patients requiring ongoing treatment with a contraindicated concomitant medication
3. Patients with another previous or current malignant disease which, in the judgement of the treating investigator, is likely to interfere with COIN treatment or assessment of response

Study & Design

• Study Type: Interventional
• Study Design: Not specified