Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis
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.
|Colorectal Cancer Small Intestine Cancer||Drug: exisulind||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Prevention
|Official Title:||Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis|
|Study Start Date:||July 1999|
|Study Completion Date:||July 1999|
|Primary Completion Date:||July 1999 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026468
|Study Chair:||James A. DiSario, MD||University of Utah|