OBJECTIVES:~Determine the ability of exisulind to inhibit growth and development of duodenal adenomas in patients with familial adenomatous polyposis.~Determine the effect on apoptosis in polyp vs mucosal tissue in these patients when treated with this drug.~OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to one of two treatment arms.~Arm I: Patients receive oral exisulind 4 times daily.~Arm II: Patients receive oral placebo 4 times daily. Treatment continues for 1 year.~PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
RATIONALE: Exisulind may be effective in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.~PURPOSE: Randomized phase II/III trial to determine the effectiveness of exisulind in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.