Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-04-02 @ 5:40 AM
Study NCT ID:
NCT00101335
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2005-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celecoxib in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D007012', 'term': 'Hypopharyngeal Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}, {'id': 'D014062', 'term': 'Tongue Neoplasms'}, {'id': 'D007972', 'term': 'Leukoplakia, Oral'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D014060', 'term': 'Tongue Diseases'}, {'id': 'D007971', 'term': 'Leukoplakia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-09', 'studyFirstSubmitDate': '2005-01-07', 'studyFirstSubmitQcDate': '2005-01-07', 'lastUpdatePostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypopharyngeal cancer', 'lip and oral cavity cancer', 'nasopharyngeal cancer', 'oropharyngeal cancer', 'tongue cancer', 'oral leukoplakia'], 'conditions': ['Head and Neck Cancer', 'Precancerous Condition']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of celecoxib may prevent or treat head and neck cancer.\n\nPURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to placebo in preventing head and neck cancer in patients with oral leukoplakia.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the clinical efficacy of celecoxib vs placebo, in terms of inducing regression of oral leukoplakia lesions, in patients with hyperplastic or dysplastic oral leukoplakia.\n\nSecondary\n\n* Determine the effect of this drug in modulating multiple intermediate biomarkers (e.g., COX-2, PPARγ, or PPARδ) in normal and hyperplastic or dysplastic oral epithelia of these patients.\n* Determine the safety of this drug in these patients.\n* Determine the cost-effectiveness of this drug as a chemopreventative agent in these patients.\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled, cross-over study. Patients are stratified according to the pathology of the leukoplakia lesion (dysplasia vs hyperplasia). Patients are randomized to 1 of 2 arms.\n\n* Arm I: Patients receive oral celecoxib twice daily for 3 months.\n* Arm II: Patients receive oral placebo twice daily for 3 months. All patients undergo biopsy. Patients then cross-over to the opposite treatment arm for 3 months.\n\nIn both arms, treatment continues in the absence of unacceptable toxicity or disease progression.\n\nPatients are followed at 1 month.\n\nPROJECTED ACCRUAL: A total of 27-60 patients (18-40 for study drug, 9-20 for placebo before cross-over) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of oral leukoplakia with hyperplasia or dysplasia\n\n * Documented by baseline biopsy of oral lesions suspicious for leukoplakia\n * For patients using dentures over the past 6 months, only lesions located on the ventral-lateral tongue or floor of the mouth are allowed\n * No leukoplakia/hyperplasia secondary to mechanical irritation\n* No carcinoma in situ of the oral cavity\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Not specified\n\nLife expectancy\n\n* At least 1 year\n\nHematopoietic\n\n* Hemoglobin ≥ 10 g/dL (women) OR ≥ 11 g/dL (men)\n\nHepatic\n\n* AST or ALT normal\n* Bilirubin normal\n\nRenal\n\n* Creatinine normal OR\n* Creatinine clearance ≥ 60 mL/min\n\nCardiovascular\n\n* No myocardial infarction within the past 12 months\n* No known active ischemic cardiac disease by stress test or echocardiogram\n\nGastrointestinal\n\n* No history of gastrointestinal hemorrhage\n* No known gastrointestinal ulcers within the past 2 years unless there is documentation of healed lesions by upper endoscopy\n* No active or suspected peptic ulcer disease\n* Negative stool guaiac test\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 2 months after study treatment\n* No use of snuff or chewing tobacco within the past 2 months\n* No active invasive malignancy within the past 3 years except nonmelanoma skin cancer or in situ carcinomas\n* No clinical evidence of chronic infectious disease\n* No clinical evidence of connective tissue disease\n* No known hypersensitivity (asthma, urticaria, or acute rhinitis induced by NSAIDs) to aspirin or other NSAIDs\n* No known hypersensitivity to sulfonamides\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* At least 6 months since prior chronic or frequent use of systemic glucocorticoids\n* No concurrent chronic or frequent use of systemic glucocorticoids\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* No prior chronic or frequent (\\> 100 mg per day aspirin equivalent) use of nonsteroidal anti-inflammatory drugs (NSAIDs) for 7 of the past 14 days\n* At least 3 months since prior experimental therapy\n* No concurrent chronic or frequent use of NSAIDs\n\n * Cardioprotective doses of aspirin ≤ 100 mg daily are allowed'}, 'identificationModule': {'nctId': 'NCT00101335', 'briefTitle': 'Celecoxib in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia', 'organization': {'class': 'OTHER', 'fullName': 'Fox Chase Cancer Center'}, 'officialTitle': 'A Phase IIb Cancer Prevention Trial of Celecoxib, a Selective COX-2 Inhibitor, in Oral Leukoplakia', 'orgStudyIdInfo': {'id': 'FCCC-02028'}, 'secondaryIdInfos': [{'id': 'CDR0000393574', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'celecoxib', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19111-2497', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Paul F. Engstrom, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fox Chase Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fox Chase Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}