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