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Status:

COMPLETED

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

Lead Sponsor:

Stony Brook University

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Colorectal Cancer

Eligibility:

All Genders

50+ years

Phase:

PHASE1

Brief 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. PUR...

Detailed Description

OBJECTIVES: Primary * Evaluate the effects of nitric oxide-releasing acetylsalicyclic acid on aberrant cryptic foci (ACF) in patients at high risk for colon cancer. Secondary * Determine the pharm...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    240 Patients enrolled

    Trial Details

    Trial ID

    NCT00331786

    Start Date

    July 1 2006

    Last Update

    February 9 2009

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Stony Brook University Cancer Center

    Stony Brook, New York, United States, 11794-8174