Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses

DISEASE CHARACTERISTICS:

* Diagnosis of Fitzpatrick skin types I, II, or III
* Sun-damaged skin with 10-40 actinic keratoses on the upper extremities (upper arms, forearms, and hands), neck, face, and scalp combined

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3,000/mm\^3
* Platelet count at least 125,000/mm\^3
* Hemoglobin at least lower limit of normal
* No significant bleeding disorder

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 1.5 times ULN
* No chronic or acute hepatic disorder

Renal:

* Creatinine no greater than 1.5 times ULN
* BUN no greater than 1.5 times ULN
* No chronic or acute renal disorder

Gastrointestinal:

* No history of or active inflammatory bowel disease
* No active pancreatitis
* Not diagnosed with esophageal, gastric, pyloric channel, or duodenal ulceration within the past 30 days

Other:

* No history of keloid formation
* No known photosensitivity disorder
* No history of hypersensitivity or adverse reaction to sulfonamides, COX-2 inhibitors, salicylates, or other NSAIDs
* No other condition that would preclude study
* No other medical or psychosocial condition that would preclude study
* No other malignancy within the past 5 years except:

  * Carcinoma in situ of the cervix
  * Curatively excised nonmelanoma skin cancer
  * Stage 0 chronic lymphocytic leukemia
  * Any cancer for which the patient is currently without evidence of disease, has not been treated for tumor within the past 6 months, has no current or planned therapy, and has an expected disease-free survival of at least 5 years
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 30 days since prior systemic immunotherapy
* No concurrent immunotherapy

Chemotherapy:

* At least 3 months since prior topical fluorouracil (5-FU)
* At least 6 months since other prior topical chemotherapy
* No concurrent topical chemotherapy, including 5-FU
* No other concurrent chemotherapy

Endocrine therapy:

* At least 6 months since prior oral or IV corticosteroids for more than 2 consecutive weeks
* At least 6 months since prior inhaled or nasal corticosteroids for more than 4 weeks duration
* At least 14 days since prior topical corticosteroids
* At least 30 days since prior nasal corticosteroids (except mometasone)
* No concurrent oral or IV corticosteroids for more than 2 consecutive weeks during any 6 month period during study
* No concurrent inhaled or nasal steroids (except mometasone) for more than 4 weeks during any 6 month period during study
* No concurrent hormonal or steroidal therapy, including topical corticosteroids
* Concurrent hormone replacement therapy (e.g., estrogen or thyroid hormone replacement) allowed

Radiotherapy:

* At least 6 months since prior local radiotherapy to areas being studied
* At least 30 days since other prior radiotherapy
* No concurrent radiotherapy, including local radiotherapy to areas being studied

Surgery:

* Not specified

Other:

* At least 30 days since prior cryotherapy to target lesions
* At least 60 days since prior laser resurfacing, dermabrasion, or chemical peels
* At least 30 days since prior investigational medication
* At least 14 days since prior topical alphahydroxyacids (e.g., glycolic acid or lactic acid) or retinoids
* At least 30 days since prior systemic psoralens or retinoids
* At least 30 days since prior treatment for esophageal, gastric, pyloric channel, or duodenal ulcers
* At least 30 days since prior aspirin (more than 100 mg/day), other nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors at a frequency of at least 3 times per week for more than 2 weeks (except cardioprotective doses of aspirin (no more than 100 mg/day)
* No concurrent systemic psoralens or retinoids
* No concurrent prescription or over-the-counter topical medications to areas being studied (e.g., vitamin A derivatives)
* No concurrent cryotherapy to target lesions
* No concurrent laser resurfacing, dermabrasion, or chemical peels
* No other concurrent investigational medications
* No concurrent fluconazole or lithium
* No concurrent chronic NSAIDs or COX-2 inhibitors (at least 3 times per week for more than 2 consecutive weeks per year)
* Concurrent cardioprotective doses of oral aspirin (100 mg per day or less) allowed
* Concurrent moisturizer/emollient or sunscreen allowed