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.

Condition	Treatment or Intervention	Phase
basal cell carcinoma of the skin squamous cell carcinoma of the skin	Drug: celecoxib  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: cancer prevention intervention  Procedure: chemoprevention of cancer  Procedure: growth factor antagonist therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  20 Years   -   60 Years,  Genders Eligible for Study:  Both

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: 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

New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting

Study chairs or principal investigators

David R. Bickers, MD,  Study Chair,  Herbert Irving Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068840; CPMC-U19-CA81888-01-UV; CPMC-IRB-9923; NCI-P01-0191; NCT00025051
Record last reviewed:  September 2004
Last Updated:  December 6, 2004
Record first received:  October 11, 2001
ClinicalTrials.gov Identifier:  NCT00025051
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08