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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
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
Compare celecoxib vs placebo in terms of preventing the development of new actinic keratoses in patients with actinic keratoses.
Time frame: baseline to 2 months after last dose
Compare these treatment regimens in terms of inducing regression of actinic keratoses in these patients.
Time frame: baseline to 2 months after last dose
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.
Time frame: baseline to 2 months after last dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Siteman Cancer Center at Barnes-Jewish Hospital
St 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