Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Diagnosis of colorectal adenocarcinoma
• * Metastatic disease
• Not curable by surgery or amenable to radiotherapy with curative intent
• Measurable disease
• * Patients with only lesions measuring ≥ 1 cm but \< 2 cm must use spiral CT scan for pre- and post-treatment tumor assessments
• No known CNS metastases or carcinomatous meningitis
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Performance status
• ECOG 0-2
• Life expectancy
• At least 12 weeks
• Hematopoietic
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hepatic
• AST ≤ 5 times upper limit of normal (ULN)
• Bilirubin ≤ 0.5 mg/dL above ULN
• Renal
• Creatinine ≤ 1.5 times ULN OR
• Creatinine clearance ≥ 60 mL/min
• Cardiovascular
• No unstable angina
• No symptomatic congestive heart failure
• No serious uncontrolled cardiac arrhythmia
• Pulmonary
• No prior clinical diagnosis of interstitial lung disease
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active or uncontrolled infection
• No other concurrent serious illness
• No pre-existing paraesthesias/dysesthesias of ≥ grade 2 that would interfere with function
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No concurrent sargramostim (GM-CSF)
• Chemotherapy
• At least 6 months since prior adjuvant chemotherapy
• No prior fluorouracil for advanced colorectal cancer
• No prior adjuvant oxaliplatin
• No prior adjuvant irinotecan
• Endocrine therapy
• Not specified
• Radiotherapy
• No prior radiotherapy to \> 25% of bone marrow
• Surgery
• At least 4 weeks since prior major surgery