Clinical Trial: Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Celecoxib in Subjects With Basal Cell Nevus Syndrome
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 Summary:
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.
Sponsor: University of California, San Francisco
Current Primary Outcome: Prevention of the development of basal cell carcinoma
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: September 13, 2001
Date Started: February 2001
Date Completion:
Last Updated: June 25, 2013
Last Verified: July 2007
