Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses
Precancerous Condition
About this trial
This is an interventional prevention trial for Precancerous Condition focused on measuring actinic keratosis
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
- University of Michigan Comprehensive Cancer Center
- Siteman Cancer Center at Barnes-Jewish Hospital
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- University of Texas - MD Anderson Cancer Center
- University of Wisconsin Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group 1 active arm
Group 2 active arm
group 2 placebo arm
receipt of active drug
receipt of active drug
receipt of placebo