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

Criteria: ECOG performance status 0-2 Platelet count >= 100,000/mm^3 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 At least 6 weeks since prior oral corticosteroids Creatinine =< 1.5 times ULN Creatine phosphokinase =< 1.5 times ULN Not pregnant or nursing At least 6 weeks since prior statins 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 Negative pregnancy test 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 Defined as 7 consecutive days for > 3 weeks OR > 21 days total during study participation Patients may be eligible for study treatment after discontinuing NSAIDs for 12 weeks, at the discretion of their health care provider No other concurrent investigational agents No planned (or likely to require) clinically indicated colonoscopy or flexible sigmoidoscopy during study treatment Bilirubin =< 1.5 times ULN Hemoglobin >= lower limit of normal AST =< 1.5 times upper limit of normal (ULN) Alkaline phosphatase =< 1.5 times ULN