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