Cetuximab + Best Supportive Care Compared With Best Supportive Care Alone in Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer

DISEASE CHARACTERISTICS: Histologically confirmed colorectal cancer Metastatic disease Epidermal growth factor receptor (EGFR)-positive by immunochemistry Measurable or evaluable disease Not amenable to standard curative therapy Best supportive care is the only available option Must have received a prior thymidylate synthase inhibitor (e.g., fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) in the adjuvant or metastatic setting Combination therapy with oxaliplatin or irinotecan allowed Must have failed* a prior regimen containing irinotecan and a prior regimen containing oxaliplatin for metastatic disease OR relapsed within 6 months after an adjuvant regimen containing irinotecan or oxaliplatin OR have documented unsuitability for such regimens No symptomatic CNS metastases NOTE: *Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen PATIENT CHARACTERISTICS: Age 16 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 75,000/mm^3 Hemoglobin ≥ 8.0 g/dL Hepatic AST and ALT ≤ 5 times upper limit of normal (ULN) Bilirubin ≤ 2.5 times ULN Renal Creatinine ≤ 1.5 times ULN Cardiovascular No uncontrolled angina No arrhythmias No cardiomyopathy No congestive heart failure No myocardial infarction* within the past 6 months NOTE: *Pre-treatment ECG as only evidence of infarction is allowed Pulmonary No severe restrictive lung disease No interstitial lung disease by chest x-ray Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 4 weeks before, during, and for 4 weeks after study treatment No active pathological condition that would preclude study participation No psychological or geographical condition that would preclude study compliance No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy No prior cetuximab No prior murine monoclonal antibody therapy (e.g., edrecolomab) Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No concurrent chemotherapy Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered Concurrent palliative radiotherapy allowed except to index lesions Surgery At least 4 weeks since prior major surgery and recovered Other No prior EGFR-targeted therapy (e.g., erlotinib or gefitinib) More than 30 days since prior experimental therapeutic agents More than 4 weeks since prior investigational agents No concurrent enrollment in another clinical study No other concurrent EGFR-targeted therapy No other concurrent non-cytotoxic experimental agents