Spots Global Cancer Trial Database for Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus

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Trial Identification

Brief Title: Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus

Official Title: Chemoprevention for Barrett's Esophagus Trial (CBET)

Study ID: NCT00005878

Conditions

Esophageal Cancer

Interventions

celecoxib

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: * 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.