Phase II Trial Of Irinotecan + 5-Fluorouracil + Leucovorin + Oxaliplatin As First-Line Treatment For Metastatic Colorectal Cancer

Date de début de l'étude : 1 mars 2004

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