Spots Global Cancer Trial Database for Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses
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Trial Identification
Brief Title: Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses
Official Title: A Phase II/III Randomized, Double-Blind, Placebo-Controlled Clinical Trial Of Celecoxib In Subjects With Actinic Keratoses
Study ID: NCT00027976
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Irvine, California, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Contact Details
Name: Craig A. Elmets, MD
Affiliation: University of Alabama at Birmingham
Role: STUDY_CHAIR
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