Nitric Oxide-Releasing Acetylsalicyclic Acid in Preventing Colorectal Cancer in Patients at High Risk of Colorectal Cancer

DISEASE CHARACTERISTICS:

At risk for colorectal cancer

History of histologically proven sporadic colon adenomas or colon cancer
At least 5 aberrant cryptic foci on sigmoidoscopy
Less than 20 prior cumulative adenomas and no heredity nonpolyposis colorectal cancer

No significant asymptomatic lesions on sigmoidoscopy, including any of the following:

Inflammation
Strictures
Anorectal lesions
Fistulae
Vascular lesions
No adenomas or colon carcinomas on flexible sigmoidoscopy
No history of gastrointestinal (GI) cancer other than colorectal cancer
No inherited colorectal cancer syndromes

PATIENT CHARACTERISTICS:

No other GI mucosal epithelial diseases (e.g., Barrett's esophagus, chronic or recurrent peptic ulcer disease, celiac sprue, or other disorders of nutrient absorption)

No active peptic ulcer disease
No history of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
No known or suspected alcohol ( > 5 glasses of wine or beer per day), drug, or medication abuse
No quantitative or qualitative platelet or coagulation abnormalities
No personal or family history of a bleeding disorder
No uncontrolled diabetes
No uncontrolled hypertension, or chronic congestive heart failure (New York Heart Association class II-IV heart disease)
No myocardial infarction, transient ischemic attack, or stroke within the past 6 months
No equilibrium disorders affecting gait or ability to stand that would preclude study participation
No involuntary change in weight (up or down) of ≥ 15% of usual body weight within the past year
Creatinine ≤ 2.0 mg/dL
No chronic liver disease or pancreatitis
No allergies to aspirin
No prior severe adverse reactions to NSAIDs such as asthma, GI bleeding, or renal insufficiency
No institutionalized, mentally disabled patients
No prisoners
Not pregnant or nursing
Fertile patients must use effective contraception
Negative pregnancy test

PRIOR CONCURRENT THERAPY:

No concurrent antibiotic prophylaxis
More than 7 days since prior nonsteroidal anti-inflammatory drug (NSAID) treatment, including aspirin
No concurrent frequent use (> 7 days in previous month) of NSAIDs, cyclooxygenase (COX)-2 inhibitors, nitrovasodilators, or oral corticosteroids
No concurrent macronutrient consumption below the 1st or above the 99th percentile of U.S. consumption
No concurrent anticoagulants, ticlopidine, and clopidogrel
More than 3 months since prior general anesthesia
More than 3 months since prior investigational agents

No concurrent NSAIDs, including aspirin or COX-2 inhibitors

Acetaminophen allowed
No concurrent nitrovasodilating drugs
More than 3 months since prior participation in other investigational trials