A Phase II/III Randomized, Double-Blind, Placebo-Controlled Clinical Trial Of Celecoxib In Subjects With Actinic Keratoses
Overview
- Phase
- Phase 2
- Intervention
- celecoxib
- Conditions
- Precancerous Condition
- Sponsor
- University of Alabama at Birmingham
- Locations
- 7
- Primary Endpoint
- Compare celecoxib vs placebo in terms of preventing the development of new actinic keratoses in patients with actinic keratoses.
- Status
- Withdrawn
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group 1 active arm
receipt of active drug
Intervention: celecoxib
Group 2 active arm
receipt of active drug
Intervention: celecoxib
group 2 placebo arm
receipt of placebo
Intervention: Placebo
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Compare these treatment regimens in terms of inducing regression of actinic keratoses in these patients.(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.(baseline to 2 months after last dose)