Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer

Exclusion Criteria

• •1. Known diagnosis of FAP, hereditary non-polyposis colon cancer (HNPCC), or inflammatory bowel disease
• •2. History of hypersensitivity to COX-2 inhibitors, sulfonamides, NSAIDs , salicylates, or ursodeoxycholic acid
• •3. Use of NSAIDs, including aspirin, at any dose during the six months prior to study entry will require a three month washout period prior to eligibility beginning with the time of the last dose. Participants must be off all NSAIDs for three months prior to study entry. Individuals on cardioprotectant aspirin at any dose will not be eligible.
• •4. History of gastroduodenal ulcers documented endoscopically would preclude a patient from participation in the trial
• •5. Known inability to participate in the scheduled follow-up tests.
• •6. Significant medical or psychiatric problems which would make the patient a poor protocol candidate, in the opinion of the principal investigator.
• •7. "Unacceptable clinical risk" to proceed (based upon the subclinical discoveries made via baseline colonoscopy and biopsies).
• •8. Patient has undergone a total colectomy
• •9. Patient has received chemotherapy within the past 6 months of randomization into study. Topical chemotherapy will be assessed on a case-by-case basis. Any history of pelvic or rectal radiation therapy will exclude a patient from participating.
• •10. History of invasive carcinoma in the past five years (except patients with Dukes A/B1 carcinoma within 5 years of entry or any stage of colorectal cancer if at least 5 years post surgical resection)
• •11. Patients with rectal cancer are excluded except for transanal excision without radiation.
• •12. Patients with acute liver disease, unexplained transaminase elevations or a history of renal stones would be excluded.
• •13. Participants will not be permitted to be randomized into the trial if any of the following laboratory values are reported at baseline : Hgb \< 10.0 g/dl, platelet count \<100,000/ul; WBC \< 3,000/ul; ALT \> 2 x upper limit of normal; AST \> 2 x upper limit of normal, and total bilirubin \>1.5mg/100ml.