Celecoxib, Leucovorin, Fluorouracil, and Oxaliplatin 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 rectal cancer, stage IV colon cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent rectal cancer, recurrent colon cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum Metastatic disease Inoperable disease (i.e., not suitable for complete carcinological surgical resection) Measurable disease or nonmeasurable disease At least 1 unidimensionally measurable lesion at least 20 mm by conventional CT scan OR 10 mm by spiral CT scan Nonmeasurable disease defined as all other lesions, including small lesions or truly nonmeasurable disease No CNS metastases No exclusive bone metastases No symptomatic ascites or pleural effusion not evacuated before study entry PATIENT CHARACTERISTICS: Age 18 to 75 Performance status WHO 0-2 Life expectancy Not specified Hematopoietic Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No known significant bleeding disorder Hepatic Alkaline phosphatase less than 3 times upper limit of normal (ULN) Renal Creatinine less than 1.5 times ULN OR Creatinine clearance at least 30 mL/min No uncontrolled hypercalcemia Cardiovascular No congestive heart failure Gastrointestinal No total or partial bowel obstruction No active gastric or duodenal ulceration or gastrointestinal bleeding within the past year No active inflammatory bowel disease Other Not pregnant or nursing Fertile patients must use effective contraception HIV negative No peripheral sensory neuropathy No known sensitivity to celecoxib, other COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides No AIDS-related illness No active infection No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy for metastatic disease Chemotherapy Prior adjuvant chemotherapy allowed provided the progression-free interval after completion of therapy is more than 6 months in duration No prior chemotherapy for metastatic disease No prior adjuvant oxaliplatin No other concurrent chemotherapy Endocrine therapy No concurrent chronic oral or IV corticosteroid use (i.e., 2 weeks or longer in duration) Radiotherapy No concurrent radiotherapy Surgery Not specified Other More than 30 days since prior investigational drugs No other concurrent investigational drugs or treatments No concurrent prophylactic fluconazole No concurrent chronic full-dose aspirin (at least 325 mg/day), other nonsteroidal anti-inflammatory drugs (NSAIDs), or other cyclooxygenase (COX)-2 inhibitors Concurrent low-dose (cardioprotective) aspirin (80 mg/day or equivalent) allowed No concurrent lithium No other concurrent anticancer therapy
Sites / Locations
- Hopital Tenon