A Phase II Study of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU), and Leucovorin (CF) in Patients With Metastatic Colorectal Carcinoma Previously Treated With Irinotecan (CPT-11)

Date de début de l'étude : 1 avril 2001

DISEASE CHARACTERISTICS: * Diagnosis of metastatic colorectal adenocarcinoma incurable by surgery or not amenable to radiotherapy with curative intent * Progressive disease no more than 3 months after completion of a prior weekly irinotecan, fluorouracil, and leucovorin calcium chemotherapy regimen * At least 1 measurable lesion At least 20 mm in at least one dimension * No known CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0-2 * Life expectancy: At least 12 weeks * Absolute neutrophil count greater than 2,000/mm3 * Platelet count at least 100,000/mm3 * Bilirubin no greater than 0.5 mg/dL above upper limit of normal (ULN) * AST no greater than 5 times ULN * Creatinine no greater than 1.5 times ULN OR creatinine clearance greater than 60 mL/min * No unstable angina No symptomatic congestive heart failure * No serious uncontrolled cardiac arrhythmia * No active or uncontrolled infection * No evidence of other serious illness * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinomas * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * No concurrent sargramostim (GM-CSF) * At least 4 weeks since prior chemotherapy * No more than 1 prior chemotherapy regimen for advanced colorectal cancer * Prior adjuvant chemotherapy allowed * No prior radiotherapy to more than 25% of bone marrow * At least 4 weeks since prior major surgery