In this Phase II, randomized double-bind study, the efficacy of Celecoxib in actinic keratosis (AK) patients will be evaluated. Eligibility criteria include female and male subjects over 18 years of age with multiple sites (at least two) of actinic keratosis identified by clinical examination and histologic confirmation of one lesion (Grade 1-3), no history of invasive cancer within five years, not requiring topical medications, and meeting SWOG performance status. Approximately 120 subjects will be randomized to Celecoxib vs. placebo. The endpoints of the study are the efficacy of Celecoxib on regression of AK when administered for one year compared to placebo and to determine the effect of Celecoxib on surrogate endpoint biomarkers of actinic keratosis and sun damaged skin.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Prevention And Control (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CN085183-001
Application #
6356131
Study Section
Project Start
1998-09-30
Project End
2001-09-29
Budget Start
2000-09-30
Budget End
2001-09-29
Support Year
Fiscal Year
2000
Total Cost
$10,000
Indirect Cost
Name
University of Alabama Birmingham
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004514360
City
Birmingham
State
AL
Country
United States
Zip Code
35294
Elmets, Craig A; Viner, Jaye L; Pentland, Alice P et al. (2010) Chemoprevention of nonmelanoma skin cancer with celecoxib: a randomized, double-blind, placebo-controlled trial. J Natl Cancer Inst 102:1835-44
Elmets, Craig A; Athar, Mohammad (2010) Targeting ornithine decarboxylase for the prevention of nonmelanoma skin cancer in humans. Cancer Prev Res (Phila) 3:8-11
Rodriguez-Burford, Cristina; Tu, John H; Mercurio, Marygail et al. (2005) Selective cyclooxygenase-2 inhibition produces heterogeneous erythema response to ultraviolet irradiation. J Invest Dermatol 125:1317-20