Combination Chemotherapy With or Without Cetuximab in Treating Patients With Stage III Colon Cancer That Was Completely Removed By Surgery
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, adenocarcinoma of the colon
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage III adenocarcinoma of the colon Must have undergone curative resection (R0) within the past 28-56 days No radiotherapy prior to surgery carcinoembryonic antigen (CEA) ≤ 1.5 times upper limit of normal (ULN) after surgery No rectal cancer located within 15 cm from the anal verge by endoscopy or under the peritoneal reflection at surgery No metastatic spread at baseline assessment No prior or concurrent CNS disease by physical exam PATIENT CHARACTERISTICS: Performance status WHO 0-1 Life expectancy At least 5 years Hematopoietic WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL Hepatic Bilirubin ≤ 1.5 times ULN AST and ALT ≤ 2.5 times ULN Alkaline phosphatase ≤ 1.5 times ULN Renal Creatinine ≤ 1.5 times ULN Cardiovascular No coronary artery disease No myocardial infarction within the past 12 months No high risk of uncontrolled arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No inflammatory bowel disease No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No significant traumatic injury within the past 28 days No known hypersensitivity to any of the components of the study drugs No medical, geographical, sociological, psychological, or legal condition that would preclude study participation No peripheral neuropathy ≥ grade 1 No other significant disease that would preclude study participation PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy Radiotherapy See Disease Characteristics No prior abdominal or pelvic irradiation Surgery See Disease Characteristics Recovered from prior surgery More than 28 days since prior major surgical procedure or open biopsy No concurrent major surgical procedure
Sites / Locations
- Hopital Duffaut
- CHU de Caen
- Hopital Robert Boulin
- Hopital Bichat - Claude Bernard
- CHU Pitie-Salpetriere
- Hopital Tenon
- Centre Hospitalier Yves Le Foll
- Nouvelle Clinique Generale
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Folfox+Cetuximab
Folfox
FOLFOX-4 Cetuximab alone every 2 weeks
FOLFOX-4 alone every 2 weeks