Celecoxib in Preventing Cancer in Patients With Rectal Polyps or Colorectal Neoplasia

Inclusion 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