Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib may be an effective way to prevent the development of basal cell carcinoma.
PURPOSE: Randomized phase II trial to determine the effectiveness of celecoxib in preventing basal cell carcinoma in patients who have basal cell nevus syndrome.
|Study Design:||Allocation: Randomized
Primary Purpose: Prevention
|Official Title:||A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Celecoxib in Subjects With Basal Cell Nevus Syndrome|
- Prevention of the development of basal cell carcinoma [ Designated as safety issue: No ]
|Study Start Date:||February 2001|
- Determine whether celecoxib prevents the development of basal cell carcinoma in patients with basal cell nevus syndrome.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral celecoxib twice daily.
- Arm II: Patients receive oral placebo twice daily. Treatment continues for 2 years in the absence of unacceptable toxicity.
Patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study.
|United States, California|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center|
|New York, New York, United States, 10032|
|Study Chair:||Ervin Epstein, MD||University of California, San Francisco|