Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed colorectal cancer

  • Metastatic, unresectable disease
• May or may not express the EGFR gene

• Measurable disease, defined as ≥ 1 measurable lesion by MRI or CT scan

  • Lesion must be outside an irradiated area

PATIENT CHARACTERISTICS:

• WHO performance status 0-1
• Life expectancy > 3 months
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Transaminases ≤ 2.5 times ULN (5 times ULN if hepatic metastases are present)
• Creatinine ≤ 1.5 times ULN
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No peripheral or symptomatic neuropathy ≥ grade 2 (NCI-CTCAE)
• No complete or partial intestinal blockage
• No intestinal inflammatory disease (e.g., Crohn's disease or ulcerative colitis)
• No chronic diarrhea
• No severe unstable cardiac disease (despite treatment)
• No myocardial infarction within the past 6 months
• No neurological or psychiatric illness, including epilepsy or dementia
• No uncontrolled active infection
• No other prior or concurrent malignancy within the past 5 years except for curatively treated basal cell skin cancer
• No psychological, familial, social, or geographic reason that would preclude study follow-up

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy for metastatic disease

  • Prior fluorouracil-based adjuvant chemotherapy allowed provided it was administered ≥ 4 weeks ago
• At least 4 weeks since prior and no other concurrent experimental therapy
• No prior irinotecan hydrochloride, oxaliplatin, or monoclonal antibody
• No prior intestinal resection (e.g., hemicolectomy or extended resection of the small intestine)