NCT00027976

Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses

A Phase II/III Randomized, Double-Blind, Placebo-Controlled Clinical Trial Of Celecoxib In Subjects With Actinic Keratoses

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be an effective way to prevent actinic keratoses. PURPOSE: Randomized phase II/III trial to determine the effectiveness of celecoxib in preventing skin cancer in patients who have actinic keratoses.

Detailed description

OBJECTIVES: * Compare celecoxib vs placebo in terms of preventing the development of new actinic keratoses in patients with actinic keratoses. * Compare these treatment regimens in terms of inducing regression of actinic keratoses in these patients. * Determine the safety of this drug in these patients. * Compare the effect of these treatment regimens on potential surrogate end-point biomarkers in areas of actinic keratosis, sun-exposed skin, and non-sun-exposed skin and correlate these biomarkers with clinical outcome in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral celecoxib twice daily for 9 months in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive oral placebo as in arm I. Patients are followed at 2 months after completing treatment. PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study.

Conditions

• Precancerous Condition

Interventions

Type	Name	Description
DRUG	celecoxib
DRUG	Placebo

Timeline

• Start date: 2001-12-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2003-01-27
• Last updated: 2013-08-05

Locations

7 sites across 1 country: United States