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.

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