Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Experimental
irinotecan + oxaliplatin + leucovorin + fluorouracil
Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before each chemotherapy course, and at the end of treatment. Patients are followed every 3 months until 5 years after registration.