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