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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of nitric oxide-releasing acetylsalicyclic acid may prevent colorectal cancer.

PURPOSE: This randomized phase I trial is studying the side effects and best dose of nitric oxide-releasing acetylsalicyclic acid in preventing colorectal cancer in patients at high risk of colorectal cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stony Brook University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aspirin; Nitric Oxide; Nitroaspirin

Criteria

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