Capecitabine, Oxaliplatin, and Gefitinib in Treating Patients With Metastatic Colorectal Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed\* colorectal cancer
• * Metastatic disease
• * The site of the primary tumor must have been confirmed endoscopically, radiologically, or surgically to be the colon or rectum NOTE: \*Confirmation is not required for recurrent metastatic disease unless an interval of \> 5 years has elapsed between the initial primary surgery and the development of metastases
• Measurable disease
• * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• No CNS metastases
• PATIENT CHARACTERISTICS:
• Age
• 18 to 80
• Performance status
• ECOG 0-1
• Life expectancy
• More than 3 months
• Hematopoietic
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL (transfusion allowed)
• Hepatic
• AST and ALT ≤ 3 times upper limit of normal (ULN)
• Bilirubin ≤ ULN
• No unstable or uncompensated hepatic disease
• Renal
• Creatinine \< 1.5 times ULN OR
• Creatinine clearance \> 60 mL/min
• No unstable or uncompensated renal disease
• Cardiovascular
• No unstable or uncompensated cardiac disease
• Pulmonary
• No evidence of clinically active interstitial lung disease
• * Asymptomatic patients with chronic stable radiographic changes are eligible
• No unstable or uncompensated respiratory disease
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study participation
• No known hypersensitivity to gefitinib or any of its excipients
• No known hypersensitivity to platinum compounds, fluorouracil, or capecitabine
• No severe or uncontrolled systemic disease
• Able to receive oral medication
• No known dihydropyrimidine dehydrogenase (DPD) deficiency
• No known peripheral neuropathy ≥ grade 1
• * Absence of deep tendon reflexes as the sole neurological abnormality allowed
• No other significant clinical disorder or laboratory finding that would preclude study participation
• No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix (phase II only)
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Not specified
• Chemotherapy
• At least 4 weeks since prior chemotherapy for metastatic colorectal cancer (phase I)
• No prior chemotherapy for metastatic disease (phase II)
• * Prior fluorouracil and leucovorin calcium in the adjuvant setting allowed provided the last treatment was administered more than 6 months before the development of metastatic disease
• No prior irinotecan and oxaliplatin (phase II)
• Endocrine therapy
• Not specified
• Radiotherapy
• No concurrent radiotherapy for colorectal cancer
• Surgery
• See Disease Characteristics
• More than 4 weeks since prior major surgery (e.g., laparotomy)
• Other
• Recovered from all prior therapy (no unresolved chronic toxicity \> grade 2)
• More than 4 weeks since prior investigational drugs
• No prior epidermal growth factor receptor inhibitor therapy (phase II)
• No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum perforatum (St. John's wort)
• No other concurrent investigational drugs
• No other concurrent systemic therapy for colorectal cancer