Gefitinib in Treating Patients With Recurrent Metastatic Colorectal Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically proven adenocarcinoma of the colon or rectum
• Measurable disease
• Evidence of new or progressive metastatic disease within 6 months of last treatment
• Must have received prior systemic treatment with fluorouracil (and/or its analogs, with or without leucovorin calcium or levamisole) and irinotecan in the adjuvant or metastatic setting
• Metastatic tumor site accessible for biopsy
• No known brain metastases
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Performance status:
• ECOG 0-2
• Life expectancy:
• More than 12 weeks
• Hematopoietic:
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hepatic:
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST or ALT no greater than 2.5 times ULN (5 times ULN if tumor involvement of the liver)
• Renal:
• Creatinine no greater than 1.5 times ULN OR
• Creatinine clearance at least 60 mL/min
• Cardiovascular:
• No New York Heart Association class III or IV heart disease
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Other:
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No ongoing active or uncontrolled infections
• Other prior malignancies allowed provided prior therapy is discontinued and no evidence of disease
• No other uncontrolled illness or psychiatric illness/social situations that would preclude study
• Must be able to take and retain oral medications
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• No prior signal transduction inhibitors (e.g., vascular endothelial growth factor-, vascular endothelial growth factor receptor-, and epidermal growth factor receptor-targeted agents) for colorectal cancer
• Chemotherapy:
• See Disease Characteristics
• At least 4 weeks since prior chemotherapy and recovered
• No other prior cytotoxic chemotherapy (e.g., oxaliplatin) for colorectal cancer
• Endocrine therapy:
• Not specified
• Radiotherapy:
• At least 4 weeks since prior radiotherapy and recovered
• Surgery:
• Not specified
• Other:
• No other prior systemic therapy for colorectal cancer
• No other prior investigational or approved agents for colorectal cancer
• No other concurrent investigational agents
• No concurrent antiretroviral therapy for HIV-positive patients