Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer

You may be eligible if

• Histologically confirmed advanced (stage IV) or recurrent adenocarcinoma of the colon or rectum
• Must have available tissue for immunohistochemical analysis
• At least one unidimensionally measurable lesion
• * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• * Tumor marker (carcinoembryonic antigen) elevation alone is insufficient for study entry
• No known brain metastases
• Performance status - ECOG 0-2
• Granulocyte count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST less than 2 times ULN (5 times ULN if liver involvement of tumor)
• Creatinine no greater than 1.5 times ULN
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Not pregnant or nursing
• Fertile patients must use effective contraception
• HIV negative
• No other severe or uncontrolled concurrent illness that would adversely impact the safety or efficacy of study therapy
• No ongoing or active infection
• No other prior malignancy unless curatively treated and no evidence of recurrence
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gefitinib
• No psychiatric illness or social situation that would preclude study compliance
• No prior chemotherapy for advanced disease
• More than 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• More than 4 weeks since prior radiotherapy and recovered
• At least 6 months since prior adjuvant therapy
• No prior epidermal growth factor receptor inhibitor
• No other concurrent investigational agents
• No other concurrent anticancer therapy
• No concurrent phenytoin, carbamazepine, barbiturates, rifampin, rifapentine, oxacarbazepine, modafinil, griseofulvin, or Hypericum perforatum