A Phase III Randomized Study of Cetuximab (Erbitux™, C225) and Best Supportive Care Versus Best Supportive Care in Patients With Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR)-Positive Colorectal Carcinoma

Date de début de l'étude : 30 décembre 2003

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