Celecoxib Polyp Prevention Trial in Participants With Resected Stage I Colon Cancer

Date de début de l'étude : 1 juillet 2004

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon * Stage I disease * Distal border of tumor ≥ 12 cm from the anal verge * Tumor completely resected within the past 90 days * Must have undergone a preoperative or postoperative colonoscopy to the cecum (or small bowel anastomosis) within the past 90 days * All observed polyps must have been removed * Patients with a history suggestive of hereditary non-polyposis colorectal cancer (HNPCC) must have a normal microsatellite instability status by immunohistochemistry or polymerase chain reaction * Patients with family history of colon cancer who have not been diagnosed with HNPCC are eligible * No prior familial adenomatous polyposis * No prior invasive cancer or carcinoma in situ of the colon or rectum * No clinical or radiologic evidence of metastatic disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * At least 10 years Hematopoietic * Complete blood count normal * Platelet count normal Hepatic * Aspartate aminotransferase (AST) normal * Bilirubin normal * Alkaline phosphatase normal Renal * Creatinine normal Cardiovascular * No active ischemic heart disease * No New York Heart Association class III or IV heart disease * No myocardial infarction within the past 6 months * No symptomatic arrhythmia * No symptomatic peripheral vascular disease or carotid disease that would preclude study participation Pulmonary * No aspirin-sensitive asthma Gastrointestinal * No history of inflammatory bowel disease * No history of upper gastrointestinal bleeding * No history of duodenal or gastric ulcer Other * No known hypersensitivity to any COX-2 inhibitor, NSAIDs, aspirin, or sulfonamides * No non-colorectal malignancy within the past 5 years except carcinoma in situ of the cervix, melanoma in situ, or basal cell or squamous cell skin cancer * No other disease that would preclude study participation * No psychiatric disorders, including history of clinical depression or addictive disorders, that would preclude giving informed consent or long-term compliance * No rheumatologic or skeletal disorders requiring chronic NSAIDs or steroid therapy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * See Disease Characteristics Other * No other concurrent investigational agents for colon cancer * No concurrent chronic use of other cyclo-oxygenase-2 (COX-2) inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs), or salicylates (e.g., aspirin) * Chronic use is defined as use for more than an average of 3 days per month * Concurrent NSAIDs allowed for up to 10 consecutive days for temporary relief due to inflammatory syndromes, injury, or postoperative pain * Cardioprotective doses of aspirin (≤ 81 mg/day or 325 mg every other day) allowed * No concurrent fluconazole or lithium