Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-02 @ 5:52 AM
Study NCT ID:
NCT00127595
Status:
TERMINATED
Last Update Posted:
2005-08-24
First Post:
2005-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C508870', 'term': 'gemcitabine-oxaliplatin regimen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 28}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-08', 'completionDateStruct': {'date': '2005-04'}, 'lastUpdateSubmitDate': '2005-08-23', 'studyFirstSubmitDate': '2005-08-05', 'studyFirstSubmitQcDate': '2005-08-05', 'lastUpdatePostDateStruct': {'date': '2005-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria)'}], 'secondaryOutcomes': [{'measure': 'overall survival'}, {'measure': 'disease free survival'}, {'measure': 'toxicity'}]}, 'conditionsModule': {'keywords': ['carcinoma of the urothelial tract'], 'conditions': ['Carcinoma, Transitional Cell']}, 'descriptionModule': {'briefSummary': 'This is a phase II monocentric study of oxaliplatin (Ox) in combination with gemcitabine (Gem; GEMOX) in patients (pts) with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Transitional cell carcinoma\n* Histologically-proven\n* Locally advanced unresectable or metastatic\n* With at least one measurable target\n* Informed consent signed\n\nExclusion Criteria:\n\n* Previous chemotherapy\n* Previous radiotherapy\n* Performance status \\>=2\n* Peripheral neuropathy \\>=1'}, 'identificationModule': {'nctId': 'NCT00127595', 'briefTitle': 'Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract', 'organization': {'class': 'OTHER', 'fullName': 'Gustave Roussy, Cancer Campus, Grand Paris'}, 'officialTitle': 'A Phase II Monocentric Study of Oxaliplatin in Combination With Gemcitabine in Patients With Advanced/Metastatic Transitional Cell Carcinoma of the Urothelial Tract', 'orgStudyIdInfo': {'id': 'GEMOX'}}, 'armsInterventionsModule': {'interventions': [{'name': 'gemcitabine, oxaliplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Christine THEODORE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gustave Roussy, Cancer Campus, Grand Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}}}}