Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses
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|ClinicalTrials.gov Identifier: NCT00027976|
Recruitment Status : Withdrawn
First Posted : January 27, 2003
Last Update Posted : August 5, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Precancerous Condition||Drug: celecoxib Drug: Placebo||Phase 2 Phase 3|
- 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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase II/III Randomized, Double-Blind, Placebo-Controlled Clinical Trial Of Celecoxib In Subjects With Actinic Keratoses|
|Study Start Date :||December 2001|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2005|
Experimental: Group 1 active arm
receipt of active drug
Experimental: Group 2 active arm
receipt of active drug
Experimental: group 2 placebo arm
receipt of placebo
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00027976
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|United States, California|
|Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center|
|Irvine, California, United States, 92697|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0314|
|United States, Missouri|
|Siteman Cancer Center at Barnes-Jewish Hospital|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|James P. Wilmot Cancer Center at University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-6164|
|Study Chair:||Craig A. Elmets, MD||University of Alabama at Birmingham|