Spots Global Cancer Trial Database for Celecoxib in Preventing Skin Cancer

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Trial Identification

Brief Title: Celecoxib in Preventing Skin Cancer

Official Title: A Phase II, Double-Blind, Placebo-Controlled Clinical Trial To Assess Celecoxib As A Chemopreventive Agent Inhibiting UV-Induced Erythema And Cutaneous Carcinogenesis As Assessed Through Surrogate Biological Markers In Biopsied Skin After Exposure Of Skin In Normal Volunteers Ages 20-60 Years Old With Fitzpatrick Type I, II, III And IV Skin To UV-Radiation From Artificial Light Sources

Study ID: NCT00025051

Conditions

Non-melanomatous Skin Cancer

Interventions

celecoxib

anti-cytokine therapy

antiangiogenesis therapy

biological therapy

cancer prevention intervention

chemoprevention of cancer

growth factor antagonist therapy

Study Description

Brief Summary: RATIONALE: Celecoxib may be effective in preventing skin cancer by decreasing redness caused by exposure to ultraviolet light and changing potential skin cancer biomarkers. It is not yet known whether celecoxib is more effective than a placebo in preventing skin cancer. PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing skin cancer in participants exposed to ultraviolet light.

Detailed Description: OBJECTIVES: * Determine whether celecoxib decreases ultraviolet(UV)-induced erythema and affects surrogate biomarkers of potential neoplastic change in participants with Fitzpatrick type I-IV skin exposed to UV light. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are randomized to one of two treatment arms. * Arm I: Participants receive oral celecoxib twice daily for approximately 120 days. * Arm II: Participants receive oral placebo twice daily for approximately 120 days. Skin biopsies of UV-exposed sites are evaluated. Participants are followed for up to 5 weeks post-treatment. PROJECTED ACCRUAL: A total of 36 participants (18 per arm) will be accrued for this study within 8 months.