A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients With Advanced Colorectal Carcinoma Previously Treated With 5-FU

Fecha de inicio: 1 de noviembre de 1999

Inclusion Criteria: Histologically or cytologically confirmed locally advanced, locally recurrent,or metastatic colorectal adenocarcinoma not curable by surgery or radiotherapy Progressive disease following: One prior fluorouracil based chemotherapy regimen for metastatic disease Failure during or within 6 months after fluorouracil based adjuvant therapy Measurable or evaluable disease No CNS metastases or carcinomatous meningitis Performance status - ECOG 0-2 At least 12 weeks Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL (transfusion allowed) Bilirubin no greater than 1.5 mg/dL AST no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Creatinine no greater than 1.5 times ULN No uncontrolled high blood pressure No unstable angina No symptomatic congestive heart failure No myocardial infarction with the past 6 months No serious uncontrolled cardiac arrhythmias No New York Heart Association class III or IV heart disease No pleural effusion or ascites that cause respiratory compromise (e.g., dyspnea grade 2 or greater) No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung Not pregnant or nursing Fertile patients must use effective contraception Fluent in English No active or uncontrolled infection No other prior malignancy within the past 5 years, except: Adequately treated basal or squamous cell skin cancer Adequately treated noninvasive carcinomas No sensory neuropathy grade 2 or greater No uncontrolled colonic or small bowel disorders (greater than 3 loose stools daily) No concurrent sargramostim (GM-CSF) At least 4 weeks since prior chemotherapy and recovered No more than 1 prior chemotherapy regimen for advanced colorectal cancer No prior irinotecan or other camptothecin derivative (e.g., topotecan) No prior oxaliplatin No other concurrent investigational chemotherapy agents At least 4 weeks since prior major radiotherapy No prior radiotherapy to greater than 25% of bone marrow At least 4 weeks since prior major surgery and recovered At least 2 weeks since prior minor surgery and recovered