Celecoxib in Preventing Skin Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Non-melanomatous Skin Cancer

Intervention / Treatment
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* Drug: celecoxib
* Procedure: anti-cytokine therapy
* Procedure: antiangiogenesis therapy
* Procedure: biological therapy
* Procedure: cancer prevention intervention
* Procedure: chemoprevention of cancer
* Procedure: growth factor antagonist therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Fitzpatrick type I-IV skin No history of photosensitivity (e.g., systemic or discoid lupus erythematosus, polymorphous light eruption, or photocontact dermatitis) No history of abnormal tanning responses or other unusual reactions to natural or artificial light sources Willing to wear sun-protective clothing and SPF 15-49 sunscreen Willing and able to restrict the frequency of high ultraviolet-exposure activities (e.g., exposure to sunlight, tanning boxes, or other artificial light sources) No history of keloid formation PATIENT CHARACTERISTICS: Age: 20 to 60 Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC ≥ 3,500/mm^3 Hemoglobin ≥ 12.0 g/dL No bleeding disorder Hepatic: Bilirubin ≤ 20% above upper limit of normal (ULN) AST and ALT ≤ 20% above ULN No chronic or acute hepatic disease Renal: Creatinine ≤ 20% above ULN No chronic or acute renal disease Gastrointestinal: No active gastrointestinal disease (e.g., inflammatory bowel disease) No pancreatic disease No esophageal, gastric, pyloric channel, or duodenal ulceration Other: No invasive cancer except nonmelanoma skin cancer cured by excision or stage I cervical cancer No hypersensitivity or adverse reactions to NSAIDs, salicylates, cyclo-oxygenase-2 (COX-2) inhibitors, or sulfonamides No condition that would preclude the use of NSAIDs No clinically significant laboratory abnormalities No medical or psychosocial condition that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile participants must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent chemo-immunotherapy Chemotherapy: See Biologic therapy At least 1 year since prior chemotherapy, including topical fluorouracil Endocrine therapy: At least 2 weeks since prior topical glucocorticoids At least 30 days since prior systemic corticosteroids No concurrent systemic glucocorticoids (inhaled corticosteroids allowed) No concurrent topical corticosteroids No concurrent hormonal therapy Hormone replacement (e.g., estrogen or thyroid replacement) allowed Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: At least 14 days since prior aspirin (> 100 mg/day) or other non-steroidal anti-inflammatory drugs (NSAIDs) taken at least 3 times per week At least 2 weeks since prior topical alpha hydroxy acids (e.g., glycolic acid or lactic acid) At least 6 months since prior oral retinoids (3 months for topical retinoids to the face) At least 30 days since prior treatment for esophageal, gastric, pyloric channel, or duodenal ulceration At least 30 days since prior investigational medication No other concurrent investigational medication No concurrent topical vitamin A derivatives and/or alpha hydroxy acids No concurrent immunosuppressive drugs No concurrent topical medication to the skin, including prescription and over-the-counter preparations (moisturizers and emollients allowed) No concurrent lithium, fluconazole, or warfarin No concurrent chronic NSAIDs (> 3 times per week for > 2 consecutive weeks per year) Concurrent cardioprotective doses of aspirin (≤ 100 mg/day) allowed Concurrent acetaminophen allowed No concurrent green tea consumption of > 2 cups per day

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: celecoxib|nan|
|Procedure: anti-cytokine therapy|nan|
|Procedure: antiangiogenesis therapy|nan|
|Procedure: biological therapy|nan|
|Procedure: cancer prevention intervention|nan|
|Procedure: chemoprevention of cancer|nan|
|Procedure: growth factor antagonist therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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basal cell carcinoma of the skin, squamous cell carcinoma of the skin