Celecoxib in Preventing Skin Cancer
Non-melanomatous Skin Cancer
About this trial
This is an interventional prevention trial for Non-melanomatous Skin Cancer focused on measuring basal cell carcinoma of the skin, squamous cell carcinoma of the skin
Eligibility 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
Sites / Locations
- Herbert Irving Comprehensive Cancer Center at Columbia University