Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
Study NCT ID:
NCT00264134
Status:
TERMINATED
Last Update Posted:
2010-01-20
First Post:
2005-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Docetaxel, Irinotecan, and Carboplatin in Extensive Stage Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2005-10'}, 'lastUpdateSubmitDate': '2010-01-18', 'studyFirstSubmitDate': '2005-12-08', 'studyFirstSubmitQcDate': '2005-12-08', 'lastUpdatePostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Objective: To determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.'}], 'secondaryOutcomes': [{'measure': 'Secondary Objective: To evaluate the dose-related toxicities of this triple regimen in patients with inoperable lung cancer.'}]}, 'conditionsModule': {'keywords': ['Non-Small Cell Lung Cancer'], 'conditions': ['Non-small Cell Lung Cancer', 'Extensive Stage Unresectable']}, 'descriptionModule': {'briefSummary': 'Primary Objective: To determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.\n\nSecondary Objective: To evaluate the dose-related toxicities of this triple regimen in patients with inoperable lung cancer.', 'detailedDescription': 'A phase I/II dose escalating study to determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older unresectable lung cancer measurable or evaluable lesions Karnofsky PS greater than or equal to 60%\n\nExclusion Criteria:\n\n* untreated CNS metastases'}, 'identificationModule': {'nctId': 'NCT00264134', 'briefTitle': 'Docetaxel, Irinotecan, and Carboplatin in Extensive Stage Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Kentuckiana Cancer Institute'}, 'officialTitle': 'A Phase I/II Trial: Docetaxel, Irinotecan, and Carboplatin in the Treatment of Extensive Stage Small Cell Lung Carcinoma', 'orgStudyIdInfo': {'id': '1047791'}, 'secondaryIdInfos': [{'id': 'CPTAIV-0020-339'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Docetaxel', 'type': 'DRUG'}, {'name': 'Irinotecan', 'type': 'DRUG'}, {'name': 'Carboplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentuckiana Cancer Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Shawn Glisson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kentuckiana Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kentuckiana Cancer Institute', 'class': 'OTHER'}}}}