A Phase II/III Randomized, Double-Blind, Placebo-Controlled Clinical Trial Of Celecoxib In Subjects With Actinic Keratoses

Inclusion Criteria

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