Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT00272558
Status:
COMPLETED
Last Update Posted:
2009-09-18
First Post:
2006-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}], 'ancestors': [{'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000077235', 'term': 'Vinorelbine'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-17', 'studyFirstSubmitDate': '2006-01-03', 'studyFirstSubmitQcDate': '2006-01-03', 'lastUpdatePostDateStruct': {'date': '2009-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response'}], 'secondaryOutcomes': [{'measure': 'Survival'}, {'measure': 'Feasibility'}]}, 'conditionsModule': {'keywords': ['Malignant Pleural Mesothelioma', 'Chemotherapy'], 'conditions': ['Malignant Pleural Mesothelioma']}, 'descriptionModule': {'briefSummary': 'The purpose is to evaluate the activity and feasibility of a two drug regimen which is partly orally and partly intravenous in advanced pleural mesothelioma.', 'detailedDescription': 'Chemotherapy with carboplatin i.v. day one in each cycle Vinorelbine i.v. day one, and orally day 8 in each cycle, repeat new cycle every 3 weeks. Total of 6 cycles.\n\nEndpoint is response rate, secondary endpoints survival and toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically verified malignant pleural Mesothelioma\n* Age above 18 years\n* Performance status 0-2\n\nExclusion Criteria:\n\n* No previous chemotherapy\n* Normal renal, liver and bone marrow function'}, 'identificationModule': {'nctId': 'NCT00272558', 'briefTitle': 'Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Phase II Study of Carboplatin and Vinorelbine i.v. (Day 1) and Orally (Day 8) for Malignant Pleural Mesothelioma', 'orgStudyIdInfo': {'id': 'MPM phase II Carbo/VNB'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Carboplatin and Vinorelbine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Dept. Oncol., Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Jens B Sorensen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept. Oncology, Rigshospitalet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}}}}