Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus
- Conditions
- Esophageal Cancer
- Registration Number
- NCT00005878
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States