Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing cancer in patients with Barrett's esophagus.
PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have Barrett's esophagus.
|Study Design:||Allocation: Randomized
Primary Purpose: Prevention
|Official Title:||Chemoprevention for Barrett's Esophagus Trial (CBET)|
|Study Start Date:||July 2000|
|Study Completion Date:||September 2005|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
- Determine the safety and efficacy of celecoxib for regression of Barrett's dysplasia in patients with low or high-grade dysplasia of the esophagus.
OUTLINE: This is a randomized, parallel, double-blind, placebo-controlled, multicenter study. Patients are stratified according to center and grade of dysplasia at baseline (low vs high). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral celecoxib twice daily for 48-96 weeks.
- Arm II: Patients receive oral placebo as in arm I. Treatment continues in both arms in the absence of unacceptable toxicity or development of adenocarcinoma of the esophagus or cancer at other sites.
Patients are followed at 12 weeks.
PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005878
|United States, Arizona|
|Veterans Affairs Medical Center - Tucson|
|Tucson, Arizona, United States, 85723|
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|United States, Illinois|
|Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)|
|Hines, Illinois, United States, 60141|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Herbert Irving Comprehensive Cancer Center|
|New York, New York, United States, 10032|
|United States, Ohio|
|Ireland Cancer Center|
|Cleveland, Ohio, United States, 44106|
|United States, Oregon|
|Veterans Affairs Medical Center - Portland|
|Portland, Oregon, United States, 97207|
|Study Chair:||Arlene A. Forastiere, MD||Sidney Kimmel Comprehensive Cancer Center|