COIN A three-arm randomised controlled trial comparing either COntinous chemotherapy plus cetuximab or INtermittent chemotherapy with standard coninuous palliative combination chemotherapy with oxaliplatin and a fluoropyrimidine in first line treatment of metastatic colorectal cancer - COI

• Conditions: Metastatic colorectal cancer; MedDRA version: 8.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancer

• Registration Number: EUCTR2004-002951-16-IE
• Lead Sponsor: Medical Research Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-14
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2421

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 advanced and / or metastatic disease, or histologically/cytologically confirmed metastatic adenocarcinoma, together with clinical and/or radiological evidence of colorectal primary tumour.

3. Inoperable metastatic or locoregional disease.

4. Unidimensionally measurable disease.

5. Baseline CT scan must be performed within 4 weeks prior to treatment.

6. No previous systemic palliative chemotherapy for metastatic disease

7. Adjuvant chemotherapy with 5FU +/- FA, capecitabine or irinotecan may have been given, if completed > 1 month prior to trial entry.

8. Rectal chemoradiotherapy with 5FU +/- FA or capecitabine may have been given, if completed > 1 month prior to trial entry.

9. WHO performance status (PS) 0, 1 or 2 and considered by responsible consultant to be fit to undergo combination chemotherapy.

10. 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) = 3 x ULN

Estimated creatinine clearance (Cockcroft; Appendix IV) =50ml/min or measured GFR (EDTA clearance) =50 ml/min.

11. For women of childbearing potential, negative pregnancy test and adequate contraceptive precautions.

12. Effective contraception for male patients if the risk of conception exists.

13. Written informed consent for participation in the trial.

14. Consent to allow surplus pathological material to be analysed for EGFR testing.

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

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 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.

4. Patients with known hypersensitivity reactions to any of the components of the study treatments.

5. Patients with brain metastases.

6. Patients who are receiving combination chemotherapy prior to the resection of operable liver metastases (but patients of uncertain operability are eligible).

7. Patients who have received any prior chemotherapy with Oxaliplatin.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified