Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-26 @ 1:12 PM
Study NCT ID:
NCT00104793
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2005-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-29', 'studyFirstSubmitDate': '2005-03-03', 'studyFirstSubmitQcDate': '2005-03-03', 'lastUpdatePostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response'}], 'secondaryOutcomes': [{'measure': 'Survival'}, {'measure': 'Progression-free survival'}]}, 'conditionsModule': {'keywords': ['extensive stage small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '22430871', 'type': 'RESULT', 'citation': 'Okishio K, Mio T, Kawahara M, Yoshioka H, Yanagihara K, Daimon T, Furuse K. A weekly combination of carboplatin and irinotecan for previously untreated extensive disease small-cell lung cancer, results of a minimum follow-up of 3 years: a multi-center Phase II trial JMTO LC02-02. Jpn J Clin Oncol. 2012 May;42(5):387-93. doi: 10.1093/jjco/hys028. Epub 2012 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving irinotecan together with carboplatin may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with newly diagnosed extensive-stage small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the response rate in patients with newly diagnosed, previously untreated extensive stage small cell lung cancer treated with irinotecan and carboplatin.\n\nSecondary\n\n* Determine the progression-free and overall survival of patients treated with this regimen.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive irinotecan IV and carboplatin IV on days 1 and 8. Treatment repeats every 21 days for 6 courses.\n\nPROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed small cell lung cancer\n\n * Extensive stage disease\n* Newly diagnosed, treatment-naive disease\n* At least 1 unidimensionally measurable lesion\n* No massive pleural or pericardial effusion by chest CT scan\n\n * Manageable effusions allowed\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 18\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* More than 3 months\n\nHematopoietic\n\n* WBC ≥ 3,000/mm\\^3\n* Absolute granulocyte count ≥ 1,500/mm\\^3\n* Hemoglobin ≥ 9.0 g/dL\n\nHepatic\n\n* ALT or AST ≤ 2 times upper limit of normal\n* Bilirubin ≤ 1.5 mg/dL\n\nRenal\n\n* Creatinine normal\n\nCardiovascular\n\n* No myocardial infarction within the past year\n* No uncontrolled hypertension\n* No unstable angina\n* No congestive heart failure\n* No ventricular arrhythmia requiring medical intervention\n* No other serious cardiovascular disease\n\nPulmonary\n\n* Arterial oxygen pressure (Pa O\\_2) ≥ 70 mm Hg\n* No interstitial pneumonitis or pulmonary fibrosis by chest x-ray\n\nOther\n\n* Not pregnant or nursing\n* No uncontrolled diabetes\n* No severe infection\n* No paralytic or obstructive ileus\n* No serious diarrhea\n* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix that is in complete remission\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No prior radiotherapy to the chest\n\n * Other prior radiotherapy allowed\n\nSurgery\n\n* At least 2 weeks since prior surgery and recovered'}, 'identificationModule': {'nctId': 'NCT00104793', 'briefTitle': 'Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'JMTO-LC02-02'}, 'secondaryIdInfos': [{'id': 'CDR0000415703', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'carboplatin', 'type': 'DRUG'}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '373-8550', 'city': 'Gunma', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Gunma Cancer Center'}, {'zip': '070-0901', 'city': 'Asahikawa', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'National Hospital Organization - Dohoku National Hospital', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'zip': '251-8550', 'city': 'Fujisawa', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Fujisawa City Hospital', 'geoPoint': {'lat': 35.34926, 'lon': 139.47666}}, {'zip': '710-8602', 'city': 'Kurashiki-shi', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Kurashiki Central Hospital'}, {'zip': '553-0003', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Kosei Nenkin Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '558-0056', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka General Medical Center', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '591-8555', 'city': 'Sakai', 'state': 'Osaka', 'country': 'Japan', 'facility': 'National Hospital Organization - Osaka National Hospital', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}, {'zip': '569-1096', 'city': 'Takatsuki', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Takatsuki Red Cross Hospital', 'geoPoint': {'lat': 34.84833, 'lon': 135.61678}}, {'zip': '561-0072', 'city': 'Yao', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Yao Tokusyu-kai General Hospital', 'geoPoint': {'lat': 34.61667, 'lon': 135.6}}, {'zip': '113-8519', 'city': 'Tokyo', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Medical and Dental University', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '737-0023', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'National Hospital Organization - Medical Center of Kure', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}], 'overallOfficials': [{'name': 'Tadashi Mio, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kyoto University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Japan Multinational Trial Organization', 'class': 'OTHER'}}}}