Celecoxib in Preventing Cancer in Patients With Rectal Polyps or Colorectal Neoplasia
Colorectal Cancer
About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring colorectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Age 18 to 49 with one of the following colorectal abnormalities: At least one adenoma that is at least 1 cm At least 3 adenomas of any size with at least 5 rectal aberrant crypt foci (ACFs) Age 50 and over with one of the following colorectal abnormalities: At least one adenoma that is at least 5 mm and at least 5 rectal ACFs History of polyps (at least 1 adenoma) within the past 5 years No history of germline cancer syndrome No stage III or IV colorectal cancer (Dukes' C or D) diagnosed within the past 6 months No current colorectal cancer No inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) PATIENT CHARACTERISTICS: Age See Disease Characteristics 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic Hemoglobin greater than 11.5 g/dL WBC greater than 3,000/mm^3 Platelet count greater than 125,000/mm^3 No significant bleeding disorder Hepatic AST and ALT no greater than 1.5 times upper limit of normal (ULN) Bilirubin no greater than 1.5 times ULN Alkaline phosphatase no greater than 1.5 times ULN No chronic or acute hepatic disorder Renal Creatinine no greater than 1.5 times ULN No chronic or acute renal disorder Cardiovascular No uncontrolled hypertension No unstable angina No congestive heart failure Pulmonary No asthma No severe chronic obstructive pulmonary disease Gastrointestinal No active gastrointestinal ulcers No history of peptic ulcer disease Other No prior hypersensitivity reaction to NSAIDs, aspirin, or sulfa drugs No medical contraindication to NSAID use Not pregnant or nursing Negative pregnancy test Fertile female patients must use effective contraception No known allergic reaction to indigo carmine No other clinically significant medical condition or abnormal laboratory value that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Anticipated use of corticosteroids less than 2 weeks over 6 months Anticipated use of mometasone less than 4 weeks over 6 months No other concurrent inhaled steroids for 30 days before or during study participation Radiotherapy No prior pelvic radiotherapy Surgery Not specified Other More than 30 days since prior investigational drugs No prior participation in this study No regular nonsteroidal anti-inflammatory drug (NSAID) or aspirin use (average of 3 or more doses per week for at least 3 months) except low-dose aspirin for cardiovascular disease prophylaxis No other concurrent investigational drugs No concurrent fluconazole or lithium
Sites / Locations
- National Naval Medical Center
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support