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

You may be eligible if

• 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