Celecoxib in Preventing Polyps in Patients Who Have Undergone Surgery for Stage I Colon Cancer
Colorectal Cancer
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring stage I colon cancer, adenocarcinoma of the colon
Eligibility Criteria
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
Sites / Locations
- Allegheny General Hospital
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Arm 1: placebo
Arm 2: celecoxib
one placebo capsule taken orally twice a day for 3 years
one 400 mg capsule taken orally twice a day for 3 years