Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses

Precancerous Condition Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Keratosis
• Keratosis, Actinic
• Precancerous Condition
• Precancerous Conditions

• NCT number: NCT00027976
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: December 2001
• Completion date: December 2005