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Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses Clinical research trials and Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses. Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses clinical trial. Subjects frequently obtain the most expert healthcare possible for their Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses  Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses
Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses
For Condition: actinic keratosis
Status: Recruiting
Sponsor(s): UAB Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be an effective way to prevent actinic keratoses. PURPOSE: Randomizedphase II/III trial to determine the effectiveness of celecoxib in preventing skin cancer in patients who have actinic keratoses.
Details: OBJECTIVES: - Compare celecoxib vs placebo in terms of preventing the development of new actinic keratoses in patients with actinic keratoses. - Compare these treatment regimens in terms of inducing regression of actinic keratoses in these patients. - Determine the safety of this drug in these patients. - Compare the effect of these treatment regimens on potential surrogate end-point biomarkers in areas of actinic keratosis, sun-exposed skin, and non-sun-exposed skin and correlate these biomarkers with clinical outcome in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral celecoxib twice daily for 9 months in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive oral placebo as in arm I. Patients are followed at 2 months. PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CraigElmets, Study Chair, UAB Comprehensive Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Madeleine Duvic 713-745-1113
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Michael Heffernan 314-362-8171
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Irvine, California, 92697
United States
Recruiting Kenneth Linden 714-456-3719
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0752
United States
Recruiting Sewon Kang 734-936-4192
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-6164
United States
Recruiting Howard Bailey 608-263-8624
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Craig Elmets 205-502-9962
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Alice Pentland 585-275-1802
Additional Information:
Study ID Numbers: CDR0000069099; UAB-NQ401A4009,NCI-P00-0161,NCI-P01-0197,UAB-NQ49902009,UAB-9833
Study Start Date:
Record last reviewed: February 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027976
Other Actinic Keratosis Studies:
1. Green Tea Extract in Treating Patients With Actinic Keratosis
2. Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses
3. Acitretin in Treating Patients With Skin Disease or Skin Cancer
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Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses
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