NCT00025051WithdrawnPhase 2
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
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC ≥ 3,500/mm^3
- •Hemoglobin ≥ 12.0 g/dL
- •No bleeding disorder
- •Bilirubin ≤ 20% above upper limit of normal (ULN)
- •AST and ALT ≤ 20% above ULN
- •No chronic or acute hepatic disease
- •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
- •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
- •Not specified
- •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
- +13 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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