Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not amenable to potentially curative surgical resection
• •Metastatic or locally recurrent disease
• •Tumor in liver or lung accessible to needle biopsy by ultrasound or CT scan guidance
• •At least 1 measurable lesion
• •* At least 20 mm by conventional techniques, including physical examination, CT scan, or MRI OR
• •* At least 10 mm by spiral CT scan
• •* Lesions on colonoscopic examination or barium studies, bone metastases, CNS lesions, and ascites are not considered measurable
• •Failed prior therapy with fluorouracil, leucovorin calcium, and irinotecan given either sequentially or in combination
• •No known brain metastases
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •ECOG 0-2
• •Life expectancy:
• •At least 3 months
• •Hematopoietic:
• •WBC at least 3,000/mm\^3
• •Absolute neutrophil count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hepatic:
• •Bilirubin no greater than 1.5 mg/dL
• •AST/ALT no greater than 2.5 times upper limit of normal
• •Renal:
• •Creatinine no greater than 1.5 mg/dL OR
• •Creatinine clearance at least 60 mL/min
• •Cardiovascular:
• •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 peripheral neuropathy greater than grade 1
• •No other concurrent uncontrolled illness that would preclude study
• •No concurrent psychiatric illness or social situation that would preclude study
• •No ongoing or active infection
• •No prior allergic reaction to compounds of similar chemical or biologic composition to oxaliplatin or gefitinib
• •No other concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix unless considered to be at less than 30% risk of relapse after completion of therapy
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •No prior epidermal growth factor inhibitor
• •At least 24 hours since prior colony-stimulating factors
• •No concurrent colony-stimulating factors during first course of study therapy
• •Chemotherapy:
• •See Disease Characteristics
• •No more than 2 prior chemotherapy regimens for metastatic disease
• •Prior adjuvant chemotherapy allowed
• •At least 4 weeks since prior cytotoxic chemotherapy and recovered
• •No prior cisplatin or oxaliplatin
• •Endocrine therapy:
• •Not specified
• •Radiotherapy:
• •At least 4 weeks since prior radiotherapy and recovered
• •Surgery:
• •See Disease Characteristics
• •At least 4 weeks since prior surgery
• •Other:
• •At least 30 days since prior investigational agents
• •Recovered from prior therapy
• •No concurrent anti-retroviral therapy for HIV
• •No other concurrent investigational or commercial agents or therapies for malignancy