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Home > "C" Clinical Trials Conditions > Celecoxib in Preventing Skin Cancer  Celecoxib in Preventing Skin Cancer
Celecoxib in Preventing Skin Cancer
For Condition: basal cell carcinoma of the skin,squamous cell carcinoma of the skin
Status: Recruiting
Sponsor(s): Herbert Irving Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Celecoxib may be effective in preventing skin cancer by decreasing redness caused by exposure to ultraviolet light and changing potential skin cancer biomarkers. It is not yet known whether celecoxib is more effective than a placebo in preventing skin cancer. PURPOSE: Randomizedphase II trial to study the effectiveness of celecoxib in preventing skin cancer in participants exposed to ultraviolet light.
Details: OBJECTIVES: - Determine whether celecoxib decreases ultraviolet(UV)-induced erythema and affects surrogate biomarkers of potential neoplastic change in participants with Fitzpatrick type I-IV skin exposed to UV light. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are randomized to one of two treatment arms. - Arm I: Participants receive oral celecoxib twice daily for approximately 120 days. - Arm II: Participants receive oral placebo twice daily for approximately 120 days. Skin biopsies of UV-exposed sites are evaluated. Participants are followed for 1 month post-treatment. PROJECTED ACCRUAL: A total of 36 participants (18 per arm) will be accrued for this study within 8 months.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 20 Years/60 Years
Genders: Both
Protocol Entry 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 at least 3,500/mm^3 - Hemoglobin at least 12.0 g/dL - No bleeding disorder Hepatic: - Bilirubin normal - AST and ALT no greater than 20% above upper limit of normal - No chronic or acute hepatic disease Renal: - Creatinine normal - 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 non-steroidal anti-inflammatory drugs (NSAIDs), salicylates, 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 - 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 (more than 100 mg/day) or other 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 (more than 3 times per week for more than 2 consecutive weeks per year) - Concurrent cardioprotective doses of aspirin (no more than 100 mg/day) allowed - Concurrent acetaminophen allowed - No concurrent tea consumption of more than 2 cups per day
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidBickers, Study Chair, Columbia University
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting David Bickers 212-305-5565
Additional Information:
Study ID Numbers: CDR0000068840; CPMC-IRB-9923,CPMC-U19-CA81888-01-UV,NCI-P01-0191
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025051
Other Squamous Cell Carcinoma Of The Skin Studies:
1. Green Tea Extract in Treating Patients With Actinic Keratosis
2. Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer
3. Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
4. Celecoxib in Preventing Skin Cancer
5. Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer
Related Studies:
Other squamous cell carcinoma of the skin Clinical Trials
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Celecoxib in Preventing Skin Cancer
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