Monoclonal Antibody Therapy in Treating Patients With Metastatic Colorectal Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed colorectal carcinoma
• * Diagnosed by fine-needle aspirate or tissue biopsy
• * Metastatic disease
• * No squamous cell carcinoma
• Relapsed or refractory after prior chemotherapy with irinotecan and a fluoropyrimidine (i.e., fluorouracil, capecitabine, or ftorafur with or without leucovorin calcium) given concurrently or sequentially
• * Progressive disease within 2 months of last dose of this prior chemotherapy for metastatic disease OR
• * Evidence of relapse within 12 months after last dose of adjuvant therapy
• Bidimensionally measurable disease
• Overexpression of epidermal growth factor r (EGFr) by immunohistochemistry
• * Must be 2+ or 3+ in at least 10% of evaluated tumor cells
• No known brain metastases
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Performance status:
• ECOG 0-1
• Life expectancy:
• Not specified
• Hematopoietic:
• Absolute neutrophil count greater than 1,500/mm3
• Platelet count greater than 100,000/mm3
• Hepatic:
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST and ALT no greater than 3 times ULN
• Alkaline phosphatase no greater than 3 times ULN
• Renal:
• Creatinine no greater than 2.2 mg/dL
• Cardiovascular:
• LVEF at least 45% by MUGA
• No myocardial infarction within the past year
• Other:
• HIV negative
• No other malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix
• No chronic medical or psychiatric condition that would preclude study
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 1 month after study
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• No prior EGFr-targeting agents or biological agents with antitumor activity
• Chemotherapy:
• See Disease Characteristics
• At least 30 days since prior systemic chemotherapy
• No more than 2 prior fluoropyrimidine regimens (e.g., fluorouracil and leucovorin calcium followed by capecitabine)
• No other prior chemotherapy, except leucovorin calcium, for colorectal carcinoma
• Endocrine therapy:
• Not specified
• Radiotherapy:
• At least 30 days since prior radiotherapy
• Surgery:
• Not specified
• Other:
• At least 30 days since other prior anticancer therapy
• No prior investigational drug with potential antitumor activity
• No other concurrent investigational drugs