A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Celecoxib in Subjects With Basal Cell Nevus Syndrome

University of California, San Francisco2 sites in 1 country60 target enrollmentFebruary 2001

ConditionsNon-melanomatous Skin Cancer

Drugscelecoxib

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Non-melanomatous Skin Cancer
Sponsor: University of California, San Francisco
Enrollment: 60
Locations: 2
Primary Endpoint: Prevention of the development of basal cell carcinoma
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2001

End Date

July 2007

Last Updated

12 years ago

Study Type

Interventional

Sex

All