Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-03-01 @ 6:02 AM
Study NCT ID:
NCT00407459
Status:
COMPLETED
Last Update Posted:
2011-09-02
First Post:
2006-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008654', 'term': 'Mesothelioma'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-31', 'studyFirstSubmitDate': '2006-12-04', 'studyFirstSubmitQcDate': '2006-12-04', 'lastUpdatePostDateStruct': {'date': '2011-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression (TTP) from first day of treatment until first observation of disease progression or death due to any cause or the last date the patient was known to be progression free or alive.', 'timeFrame': 'At the end of study'}], 'secondaryOutcomes': [{'measure': 'Response rate (RR) assessed according to modified RECIST criteria for Malignant Pleural Mesothelioma.', 'timeFrame': 'Two months after the end of enrollment'}, {'measure': 'Overall survival (OS) computed as the time between the first day of treatment and the date of death or the last date the patient was known to be alive.', 'timeFrame': 'At the end of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mesothelioma']}, 'referencesModule': {'references': [{'pmid': '16549838', 'type': 'BACKGROUND', 'citation': 'Ceresoli GL, Zucali PA, Favaretto AG, Grossi F, Bidoli P, Del Conte G, Ceribelli A, Bearz A, Morenghi E, Cavina R, Marangolo M, Parra HJ, Santoro A. Phase II study of pemetrexed plus carboplatin in malignant pleural mesothelioma. J Clin Oncol. 2006 Mar 20;24(9):1443-8. doi: 10.1200/JCO.2005.04.3190.'}, {'pmid': '17008700', 'type': 'BACKGROUND', 'citation': 'Ceresoli GL, Chiti A, Zucali PA, Rodari M, Lutman RF, Salamina S, Incarbone M, Alloisio M, Santoro A. Early response evaluation in malignant pleural mesothelioma by positron emission tomography with [18F]fluorodeoxyglucose. J Clin Oncol. 2006 Oct 1;24(28):4587-93. doi: 10.1200/JCO.2006.06.8999.'}, {'pmid': '23860535', 'type': 'DERIVED', 'citation': 'Ceresoli GL, Zucali PA, Mencoboni M, Botta M, Grossi F, Cortinovis D, Zilembo N, Ripa C, Tiseo M, Favaretto AG, Soto-Parra H, De Vincenzo F, Bruzzone A, Lorenzi E, Gianoncelli L, Ercoli B, Giordano L, Santoro A. Phase II study of pemetrexed and carboplatin plus bevacizumab as first-line therapy in malignant pleural mesothelioma. Br J Cancer. 2013 Aug 6;109(3):552-8. doi: 10.1038/bjc.2013.368. Epub 2013 Jul 16.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess antitumor activity of the combination of bevacizumab, pemetrexed and carboplatin, in terms of time to progression.', 'detailedDescription': 'Secondary endpoints are to evaluate:\n\n* the objective response rate (RR) of the combination;\n* the toxicity and the safety profile of the combination;\n* the duration of response (RD) and time to treatment failure (TTF);\n* the overall survival (OS)\n* RR, TTP and OS according to baseline plasma VEGF levels (introduced with Amendment 1 dated 8/11/2007)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven malignant pleural mesothelioma, inoperable, non previously treated with chemotherapy including intracavitary administration\n* PS 0-1\n* Measurable and/or evaluable lesions according to RECIST criteria\n* Adequate organ function\n\nExclusion Criteria:\n\n* Uncontrolled hypertension\n* Evidence of bleeding diathesis or coagulopathy\n* Pregnancy or breast-feeding'}, 'identificationModule': {'nctId': 'NCT00407459', 'briefTitle': 'Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-line Therapy in Patients With Malignant Pleural Mesothelioma', 'orgStudyIdInfo': {'id': 'ONC-2006-003'}, 'secondaryIdInfos': [{'id': 'EUDRACT 2006-004429-27'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Bevacizumab, Pemetrexed, Carboplatin', 'type': 'DRUG', 'otherNames': ['Avastin', 'Alimta', 'Carboplatin'], 'description': '* Bevacizumab: 15 mg/kg intravenous infusion over 30 to 90 minutes, following chemotherapy, on Day 1 every 3 weeks\n* Pemetrexed: 500 mg/m2 intravenous infusion over 10 minutes on Day 1 every 3 weeks\n* Carboplatin: AUC 5 intravenous infusion over 1 hour on Day 1 every 3 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milan', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'overallOfficials': [{'name': 'Armando Santoro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Clinico Humanitas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Armando Santoro, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Armando Santoro, MD', 'investigatorAffiliation': 'Istituto Clinico Humanitas'}}}}