Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
- Conditions
- Non-melanomatous Skin Cancer
- Registration Number
- NCT00023621
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevention of the development of basal cell carcinoma
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
🇺🇸New York, New York, United States