Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT00319969
Status:
COMPLETED
Last Update Posted:
2009-09-30
First Post:
2006-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Comparing Amrubicin Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Responded to Prior Therapy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': 'C055866', 'term': 'amrubicin'}, {'id': 'D019772', 'term': 'Topotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2009-09', 'dispFirstSubmitDate': '2009-09-28', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-28', 'studyFirstSubmitDate': '2006-04-27', 'dispFirstSubmitQcDate': '2009-09-28', 'studyFirstSubmitQcDate': '2006-04-27', 'dispFirstPostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective tumor response rate', 'timeFrame': 'Until Disease Progression'}], 'secondaryOutcomes': [{'measure': 'Time to tumor progression', 'timeFrame': 'Until Disease Progression'}, {'measure': 'Progression free survival', 'timeFrame': 'Until death or disease progression'}, {'measure': 'Overall survival (median survival time; 1 year survival)', 'timeFrame': 'Until death'}, {'measure': 'Toxicity profile', 'timeFrame': 'Until 30 days after final dose'}, {'measure': 'Incidence of cumulative cardiomyopathy', 'timeFrame': 'Until end of study participation'}, {'measure': 'Regression of CNS metastases', 'timeFrame': 'Until disease progression'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['small cell lung cancer', 'amrubicin'], 'conditions': ['Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the objective tumor response rate of amrubicin or standard topotecan therapy when administered as second-line therapy to ED-SCLC patients who have chemotherapy sensitive recurrent or progressive.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological diagnosis of SCLC\n* Extensive disease (ED) at time of study entry\n* Response to first-line platinum-based chemotherapy\n* Recurrent or progressive SCLC ≥90 days after completion of first-line therapy\n* At least 18 years of age\n* ECOG Performance Status of 0, 1, or 2\n* Measurable disease defined by RECIST criteria\n\n * Measurable disease: The presence of at least one measurable lesion. If only one lesion is present, the neoplastic nature of the disease site should be confirmed by histology and/or cytology.\n * Measurable lesion: Lesions that can be accurately measured in at least one dimension with the longest diameter ≥20mm using conventional techniques or ≥10mm using spiral CT scans.\n\nCT (including spiral CT) scans and MRI are the preferred methods of measurement; however, chest x-rays are acceptable if the leions are clearly defined and surrounded by aerated lung. Clinically detected lesions will only be considered measurable when they are superficial (eg., skin nodules and palpable lymph nodes). For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion is required.\n\n* Adequate organ function including the following:\n\n * Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥1500 cells/μL, platelet count ≥100,000 cells/μL and hemoglobin ≥9 g/dL\n * Hepatic: bilirubin ≤1.5 X ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 X ULN\n * Renal: serum creatinine \\<2.0mg/dL or calculated creatinine clearance \\>60mL/min\n * Cardiac: Left ventricular ejection fraction (LVEF) ≥50%\n* Negative serum pregnancy test at the time of enrollment for women of child-bearing potential. For men and women of child-producing potential, use of effective contraceptive methods during the study.\n* Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments\n\nExclusion Criteria:\n\n* Pregnant or nursing women\n* Chest radiotherapy within the previous 28 days or other radiotherapy within the previous 14 days. Recovery from the acute toxic effects of radiation required prior to study enrollment. Measurable lesions that have been previously irradiated must be enlarging to be considered target lesions. Prior radiation therapy allowed to \\<25% of the bone marrow.\n* More than 1 prior chemotherapy regimen for SCLC\n* Prior anthracycline treatment\n* Participation in any investigational drug study within 28 days prior to study entry\n* Patients with second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence; prior low grade \\[Gleason score ≤6\\] localized prostate cancer is allowed)\n* Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.\n* Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases are allowed. The patient must be stable after radiotherapy for ≥2 weeks and off corticosteroids for ≥1 week.\n* History of interstitial lung disease or pulmonary fibrosis'}, 'identificationModule': {'nctId': 'NCT00319969', 'briefTitle': 'Study Comparing Amrubicin Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Responded to Prior Therapy.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Randomized Phase 2 Trial Comparing Amrubicin Versus Topotecan as Second-Line Treatment in Patients With Extensive Small Cell Lung Cancer Sensitive to First-Line Chemotherapy', 'orgStudyIdInfo': {'id': 'CNF3140-SCLC-05004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Amrubicin 40mg/m\\<2\\> IV days 1, 2, 3 of each 21-day cycle until disease progression.', 'interventionNames': ['Drug: Amrubicin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Topotecan 1.5mg/m\\<2\\> IV, days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression.', 'interventionNames': ['Drug: Topotecan']}], 'interventions': [{'name': 'Amrubicin', 'type': 'DRUG', 'description': 'Amrubicin 40mg/m\\<2\\> IV days 1, 2, 3 of each 21-day cycle until disease progression.', 'armGroupLabels': ['1']}, {'name': 'Topotecan', 'type': 'DRUG', 'otherNames': ['Hycamtin(R)'], 'description': 'Topotecan 1.5mg/m\\<2\\> IV days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Hematology & Oncology', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hematology Oncology Associates', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Medical Center - Comprehensive Cancer Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Center - Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Center - Sky Ridge', 'geoPoint': {'lat': 39.55171, 'lon': -104.8863}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Ocala Oncology Center', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer Centers of Florida, PA', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'John B. Amos Cancer Center', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '60714', 'city': 'Niles', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cancer Care & Hematology Specialists of Chicago', 'geoPoint': {'lat': 42.01892, 'lon': -87.80284}}, {'zip': '61602', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Oncology & Hematology of Central Illinois', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '62301', 'city': 'Quincy', 'state': 'Illinois', 'country': 'United States', 'facility': 'Blessing Cancer Center', 'geoPoint': {'lat': 39.9356, 'lon': -91.40987}}, {'zip': '46227', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Central Indiana Cancer Centers', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '47802', 'city': 'Terre Haute', 'state': 'Indiana', 'country': 'United States', 'facility': 'Hope Center', 'geoPoint': {'lat': 39.4667, 'lon': -87.41391}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Healthcare - Louisville Oncology', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sinai Hospital of Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital - The Bunting Blaustein Cancer Research Building', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21044', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Oncology Hematology, PA', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '21157', 'city': 'Westminster', 'state': 'Maryland', 'country': 'United States', 'facility': 'Alliance Hematology Oncology, PA - Carroll County Cancer Center', 'geoPoint': {'lat': 39.57538, 'lon': -76.99581}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Oncology Hematology, PA', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Missouri Cancer Associates', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '64507', 'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Joseph Oncology, Inc.', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'zip': '63136', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Hematology/Oncology Consultants', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Arch Medical Services - Center for Cancer Care & Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Comprehensive Cancer Centers of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'New York Oncology Hematology, PC', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University - Regional Oncology Center', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '28602', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Northwestern Carolina Oncology & Hematology', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cancer Centers of North Carolina', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Willamette Valley Cancer Center', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Northwest Cancer Specialists', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18704', 'city': 'Kingston', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Medical Oncology Associates', 'geoPoint': {'lat': 41.26175, 'lon': -75.89686}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Cancer Centers of the Carolinas', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology Cancer Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75230-2510', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Cancer Center at Medical City', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology, PA', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - 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Deke Slayton Cancer Center', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Oncology Associates', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '24153', 'city': 'Salem', 'state': 'Virginia', 'country': 'United States', 'facility': 'Oncology & Hematology Associates of SW Virginia, Inc.', 'geoPoint': {'lat': 37.29347, 'lon': -80.05476}}, {'zip': '98133', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Puget Sound Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98684', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Cancer Specialists - Vancouver Cancer Center', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}], 'overallOfficials': [{'name': 'Richard S Ungerleider, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Theradex'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celgene Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Kathy Knapp, Clinical Program Manager', 'oldOrganization': 'Pharmion Corporation'}}}}