Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 5:31 AM
Study NCT ID:
NCT00388960
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2006-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Amrubicin With or Without Cisplatin Versus Etoposide-cisplatin for Extensive Stage Small Cell Lung Cancer
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': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'dispFirstSubmitDate': '2012-05-31', 'completionDateStruct': {'date': '2010-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2006-10-13', 'dispFirstSubmitQcDate': '2012-05-31', 'studyFirstSubmitQcDate': '2006-10-13', 'dispFirstPostDateStruct': {'date': '2012-06-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective tumor response rate according to RECIST criteria measured every 2 cycles (every 6 weeks)', 'timeFrame': 'Until Disease Progression'}], 'secondaryOutcomes': [{'measure': 'Toxicity', 'timeFrame': 'Until 30 days after last protocol treatment'}, {'measure': 'Progression-free survival', 'timeFrame': 'Until disease progression or death'}, {'measure': 'Overall survival', 'timeFrame': 'Until death'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['small cell lung cancer', 'amrubicin'], 'conditions': ['Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '21684151', 'type': 'BACKGROUND', 'citation': "O'Brien ME, Konopa K, Lorigan P, Bosquee L, Marshall E, Bustin F, Margerit S, Fink C, Stigt JA, Dingemans AM, Hasan B, Van Meerbeeck J, Baas P. Randomised phase II study of amrubicin as single agent or in combination with cisplatin versus cisplatin etoposide as first-line treatment in patients with extensive stage small cell lung cancer - EORTC 08062. Eur J Cancer. 2011 Oct;47(15):2322-30. doi: 10.1016/j.ejca.2011.05.020. Epub 2011 Jun 16."}, {'pmid': '30187833', 'type': 'BACKGROUND', 'citation': 'Liddell RP, Evans NS. May-Thurner syndrome. Vasc Med. 2018 Oct;23(5):493-496. doi: 10.1177/1358863X18794276. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to document the activity and safety of single agent amrubicin, amrubicin combined with cisplatin, and etoposide combined with cisplatin as first-line treatment in extensive disease small cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically/cytologically proven small cell lung cancer\n* Extensive disease\n* Measurable disease\n* World Health Organization (WHO) performance status 0-2\n* Age 18 years or older\n* Normal baseline cardiac function\n* No prior systemic chemotherapy for small cell lung cancer\n* Adequate organ function including bone marrow, kidney, and liver\n* No history of interstitial lung disease or pulmonary fibrosis\n* No history of prior malignancy unless patient has been disease free for greater than 5 years, or the tumour was a non-melanoma skin cancer or in-situ carcinoma of the cervix\n* No pregnancy or breast feeding; patients of child-bearing potential must agree to use an appropriate method of contraception\n* Written informed consent before randomization\n\nExclusion criteria:\n\n* Pre-existing peripheral neuropathy (greater than Grade 1, CTCAE version 3.0)\n* Uncontrolled or severe cardiovascular disease\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule'}, 'identificationModule': {'nctId': 'NCT00388960', 'briefTitle': 'Study of Amrubicin With or Without Cisplatin Versus Etoposide-cisplatin for Extensive Stage Small Cell Lung Cancer', 'nctIdAliases': ['NCT00424073'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'Randomized Phase II Study of Amrubicin as Single Agent or in Combination With Cisplatin Versus Etoposide-cisplatin as First-line Treatment in Patients With Extensive Stage SCLC (ES)', 'orgStudyIdInfo': {'id': 'EORTC Protocol 08062'}, 'secondaryIdInfos': [{'id': '2006-001956-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amrubicin', 'description': 'Amrubicin 45mg/m\\<2\\> IV days 1, 2, 3 of each 21-day cycle until disease progression.', 'interventionNames': ['Drug: Amrubicin']}, {'type': 'EXPERIMENTAL', 'label': 'Amrubicin plus Cisplatin', 'description': 'Amrubicin 40mg/m\\<2\\> IV days 1, 2, 3 plus cisplatin 60mg/m\\<2\\> IV day 1 of each 21-day cycle until disease progression.', 'interventionNames': ['Drug: Amrubicin', 'Drug: Cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cisplatin plus etoposide', 'description': 'Cisplatin 75mg/m\\<2\\> IV day 1 plus etoposide 100mg/m\\<2\\> IV day 1 and 200mg/m\\<2\\> orally days 2, 3 or etoposide 100mg/m\\<2\\> IV days 1, 2, 3 each 21-day cycle until disease progression.', 'interventionNames': ['Drug: Cisplatin', 'Drug: Etoposide']}], 'interventions': [{'name': 'Amrubicin', 'type': 'DRUG', 'description': 'Amrubicin 45mg/m\\<2\\> IV days 1, 2 3 of each 21-day cycle until disease progression.\n\nAmrubicin 40mg/m\\<2\\> IV days 1, 2, 3 plus cisplatin 60mg/m\\<2\\> day 1 of each 21-day cycle until disease progression.', 'armGroupLabels': ['Amrubicin', 'Amrubicin plus Cisplatin']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Amrubicin 40mg/m\\<2\\> IV days 1, 2, 3 plus Cisplatin 60mg/m\\<2\\> day 1 of each 21-day cycle until disease progression.\n\nCisplatin 75mg/m\\<2\\> IV day 1 plus etoposide 100mg/m\\<2\\> IV day 1 and 200mg/m\\<2\\> orally days 2, 3 or etoposide 100mg/m\\<2\\> IV days 1, 2, 3 of each 21-day cycle until disease progression.', 'armGroupLabels': ['Amrubicin plus Cisplatin', 'Cisplatin plus etoposide']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'Cisplatin 75mg/m\\<2\\> IV day 1 plus etoposide 100mg/m\\<2\\> IV day 1 and 200mg/m\\<2\\> orally days 2, 3 or etoposide 100mg/m\\<2\\> IV days 1, 2, 3 of each 21-day cycle until disease progression.', 'armGroupLabels': ['Cisplatin plus etoposide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universiteit Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '1BE', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Domaine Universitaire du Sart-Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Regional de la Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '5000', 'city': 'Namur', 'country': 'Belgium', 'facility': 'Clinique Sainte Elisabeth', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}, {'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'Instituto Nazionale per la Ricerca sul Cancro', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'Universita Degli Studi Di Udine', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'The Netherlands Cancer Institute Antoni Van Leeuwenhoekziekenhuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '7500 KA', 'city': 'Enschede', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente - Dept of Pulmonary Diseases', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'zip': '2300RC', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Centre', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '6202', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '8001', 'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala Kliniek', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'zip': '80211', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Medical University of Gdansk - Dept Radiotherapy', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': 'CH684JY', 'city': 'Bebington', 'state': 'Merseyside', 'country': 'United Kingdom', 'facility': 'Clatterbridge Centre for Oncology NHS Trust', 'geoPoint': {'lat': 53.35, 'lon': -3.01667}}, {'zip': 'D01 9SY', 'city': 'Dundee', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'University of Dundee - Ninewells Hospital', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'BT9 7AB', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Belfast City Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'HU8 9HE', 'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Princess Royal Hospital', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'SM2 5PT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Marsden Hospital, London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Christie Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NE4 6BE', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Sir Bobby Robson Cancer Trials Research Centre', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': '(Surrey) SM2 5PT', 'city': 'Sutton', 'country': 'United Kingdom', 'facility': 'Royal Marsden Hospital Lung Unit', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': "Mary O'Brien, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Marsden Hospital, London, UK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celgene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}