Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-01 @ 5:37 PM
Study NCT ID:
NCT00025051
Status:
WITHDRAWN
Last Update Posted:
2013-03-22
First Post:
2001-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celecoxib in Preventing Skin Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D018890', 'term': 'Chemoprevention'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'lastUpdateSubmitDate': '2013-03-21', 'studyFirstSubmitDate': '2001-10-11', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['basal cell carcinoma of the skin', 'squamous cell carcinoma of the skin'], 'conditions': ['Non-melanomatous Skin Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing skin cancer in participants exposed to ultraviolet light.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are randomized to one of two treatment arms.\n\n* Arm I: Participants receive oral celecoxib twice daily for approximately 120 days.\n* Arm II: Participants receive oral placebo twice daily for approximately 120 days.\n\nSkin biopsies of UV-exposed sites are evaluated.\n\nParticipants are followed for up to 5 weeks post-treatment.\n\nPROJECTED ACCRUAL: A total of 36 participants (18 per arm) will be accrued for this study within 8 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Fitzpatrick type I-IV skin\n* No history of photosensitivity (e.g., systemic or discoid lupus erythematosus, polymorphous light eruption, or photocontact dermatitis)\n* No history of abnormal tanning responses or other unusual reactions to natural or artificial light sources\n* Willing to wear sun-protective clothing and SPF 15-49 sunscreen\n* Willing and able to restrict the frequency of high ultraviolet-exposure activities (e.g., exposure to sunlight, tanning boxes, or other artificial light sources)\n* No history of keloid formation\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 20 to 60\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC ≥ 3,500/mm\\^3\n* Hemoglobin ≥ 12.0 g/dL\n* No bleeding disorder\n\nHepatic:\n\n* Bilirubin ≤ 20% above upper limit of normal (ULN)\n* AST and ALT ≤ 20% above ULN\n* No chronic or acute hepatic disease\n\nRenal:\n\n* Creatinine ≤ 20% above ULN\n* No chronic or acute renal disease\n\nGastrointestinal:\n\n* No active gastrointestinal disease (e.g., inflammatory bowel disease)\n* No pancreatic disease\n* No esophageal, gastric, pyloric channel, or duodenal ulceration\n\nOther:\n\n* No invasive cancer except nonmelanoma skin cancer cured by excision or stage I cervical cancer\n* No hypersensitivity or adverse reactions to NSAIDs, salicylates, cyclo-oxygenase-2 (COX-2) inhibitors, or sulfonamides\n* No condition that would preclude the use of NSAIDs\n* No clinically significant laboratory abnormalities\n* No medical or psychosocial condition that would preclude study participation\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile participants must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent chemo-immunotherapy\n\nChemotherapy:\n\n* See Biologic therapy\n* At least 1 year since prior chemotherapy, including topical fluorouracil\n\nEndocrine therapy:\n\n* At least 2 weeks since prior topical glucocorticoids\n* At least 30 days since prior systemic corticosteroids\n* No concurrent systemic glucocorticoids (inhaled corticosteroids allowed)\n* No concurrent topical corticosteroids\n* No concurrent hormonal therapy\n* Hormone replacement (e.g., estrogen or thyroid replacement) allowed\n\nRadiotherapy:\n\n* No concurrent radiotherapy\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* 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\n* At least 2 weeks since prior topical alpha hydroxy acids (e.g., glycolic acid or lactic acid)\n* At least 6 months since prior oral retinoids (3 months for topical retinoids to the face)\n* At least 30 days since prior treatment for esophageal, gastric, pyloric channel, or duodenal ulceration\n* At least 30 days since prior investigational medication\n* No other concurrent investigational medication\n* No concurrent topical vitamin A derivatives and/or alpha hydroxy acids\n* No concurrent immunosuppressive drugs\n* No concurrent topical medication to the skin, including prescription and over-the-counter preparations (moisturizers and emollients allowed)\n* No concurrent lithium, fluconazole, or warfarin\n* No concurrent chronic NSAIDs (\\> 3 times per week for \\> 2 consecutive weeks per year)\n* Concurrent cardioprotective doses of aspirin (≤ 100 mg/day) allowed\n* Concurrent acetaminophen allowed\n* No concurrent green tea consumption of \\> 2 cups per day'}, 'identificationModule': {'nctId': 'NCT00025051', 'briefTitle': 'Celecoxib in Preventing Skin Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II, Double-Blind, Placebo-Controlled Clinical Trial To Assess Celecoxib As A Chemopreventive Agent Inhibiting UV-Induced Erythema And Cutaneous Carcinogenesis As Assessed Through Surrogate Biological Markers In Biopsied Skin After Exposure Of Skin In Normal Volunteers Ages 20-60 Years Old With Fitzpatrick Type I, II, III And IV Skin To UV-Radiation From Artificial Light Sources', 'orgStudyIdInfo': {'id': 'CDR0000068840'}, 'secondaryIdInfos': [{'id': 'CPMC-U19-CA81888-01-UV'}, {'id': 'CPMC-IRB-9923'}, {'id': 'NCI-P01-0191'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'celecoxib', 'type': 'DRUG'}, {'name': 'anti-cytokine therapy', 'type': 'PROCEDURE'}, {'name': 'antiangiogenesis therapy', 'type': 'PROCEDURE'}, {'name': 'biological therapy', 'type': 'PROCEDURE'}, {'name': 'cancer prevention intervention', 'type': 'PROCEDURE'}, {'name': 'chemoprevention of cancer', 'type': 'PROCEDURE'}, {'name': 'growth factor antagonist therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Herbert Irving Comprehensive Cancer Center at Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'David R. Bickers, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Herbert Irving Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}}}}