Atorvastatin, Oligofructose-Enriched Inulin, or Sulindac in Preventing Cancer in Patients at Increased Risk of Developing Colorectal Neoplasia

DISEASE CHARACTERISTICS:

• At increased risk for developing sporadic colorectal neoplasia, as defined by 1 of the following:

  • History of colon cancer (excluding stage IV or Dukes' D tumors)

    • Must have completed prior adjuvant therapy for colon cancer ≥ 12 months ago

  • History of colorectal adenomas, meeting any of the following criteria:

    • ≥ 1 cm in diameter
    • ≥ 3 in total number
    • Any component of villous morphology
    • High-grade dysplasia

• At least 5 rectal aberrant cryptic foci (ACF), by magnification chromoendoscopy, meeting both of the following criteria:

  • At least 5 aggregated crypts in a single grouping (maximum spacing between crypts must be ≤ 2 times the average crypt diameter)
  • Crypt diameter ≥ 1.5 times the diameter of surrounding normal crypts
• No history of rectal cancer, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Hemoglobin ≥ lower limit of normal
• Platelet count ≥ 100,000/mm³
• AST ≤ 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 1.5 times ULN
• Bilirubin ≤ 1.5 times ULN
• Creatinine ≤ 1.5 times ULN
• Creatine phosphokinase ≤ 1.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must agree to use effective contraception
• No history of inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis)
• No invasive malignancy within the past 5 years except nonmelanoma skin cancer or colorectal cancer
• No history of endoscopically-confirmed peptic ulcer disease
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to the study agents
• No history of chronic liver disease or unexplained persistent elevations of serum transaminases
• No history of allergic-type reactions, including asthma or urticaria, to aspirin or NSAIDs

• No uncontrolled intercurrent illness including, but not limited to, any of the following:

  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situations that would preclude study compliance

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 6 weeks since prior oral corticosteroids
• At least 6 weeks since prior statins

• At least 6 months since prior and no concurrent regular use* of nonsteroidal anti-inflammatory drugs** (NSAIDs) or statins

  • Concurrent aspirin at cardioprotective doses (≤ 162.5 mg/day or 325 mg every other day) allowed
• No prior rectal surgery involving mucosal resection
• No prior pelvic radiation therapy
• No concurrent regular use* of cyclooxygenase-2 inhibitors
• No concurrent anticoagulant drugs (i.e., warfarin, heparin, clopidogrel bisulfate, or extended-release dipyridamole)

• No concurrent use of any of the following:

  • Fibrates (e.g., gemfibrozil or fenofibrate)
  • Cyclosporine
  • Erythromycin or macrolide antibiotics
  • Protease inhibitors
  • Azole antifungals
  • Diltiazem
  • Verapamil
  • Compounds containing niacin or nicotinic acid
• No other concurrent investigational agents
• No planned (or likely to require) clinically indicated colonoscopy or flexible sigmoidoscopy during study treatment NOTE: *Defined as 7 consecutive days for > 3 weeks OR > 21 days total during study participation

NOTE: **Patients may be eligible for study treatment after discontinuing NSAIDs for 12 weeks, at the discretion of their health care provider