Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-04-04 @ 11:37 PM
Study NCT ID:
NCT00651456
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2008-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesothelioma Avastin Plus Pemetrexed-cisplatin Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, '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': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'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': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 448}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-10', 'studyFirstSubmitDate': '2008-03-29', 'studyFirstSubmitQcDate': '2008-04-01', 'lastUpdatePostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Medico-economic assessments of drugs (direct/indirect costs)', 'timeFrame': '3-month'}], 'primaryOutcomes': [{'measure': '% of patients with controled disease (responder and stable patients) at 6 months', 'timeFrame': '3-month'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'month'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v3.0', 'timeFrame': 'month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mesothelioma']}, 'referencesModule': {'references': [{'pmid': '26719230', 'type': 'RESULT', 'citation': 'Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Riviere F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-1414. doi: 10.1016/S0140-6736(15)01238-6. Epub 2015 Dec 21.'}, {'pmid': '37393757', 'type': 'DERIVED', 'citation': 'Levallet G, Dubois F, Elie N, Creveuil C, Brosseau S, Danel C, Scherpereel A, Lantuejoul S, Mazieres J, Greillier L, Audigier-Valette C, Bergot E, Moro-Sibilot D, Molinier O, Lena H, Monnet I, Morin F, Gounant V, Zalcman G. VEGFR2 and CD34 expression associated with longer survival in patients with pleural mesothelioma in the IFCT-GFPC-0701 MAPS phase 3 trial. Lung Cancer. 2023 Aug;182:107287. doi: 10.1016/j.lungcan.2023.107287. Epub 2023 Jun 26.'}, {'pmid': '31279641', 'type': 'DERIVED', 'citation': 'Brosseau S, Danel C, Scherpereel A, Mazieres J, Lantuejoul S, Margery J, Greillier L, Audigier-Valette C, Gounant V, Antoine M, Moro-Sibilot D, Rouquette I, Molinier O, Corre R, Monnet I, Langlais A, Morin F, Bergot E, Zalcman G, Levallet G. Shorter Survival in Malignant Pleural Mesothelioma Patients With High PD-L1 Expression Associated With Sarcomatoid or Biphasic Histology Subtype: A Series of 214 Cases From the Bio-MAPS Cohort. Clin Lung Cancer. 2019 Sep;20(5):e564-e575. doi: 10.1016/j.cllc.2019.04.010. Epub 2019 May 13.'}, {'pmid': '30967649', 'type': 'DERIVED', 'citation': 'Ribi K, Luo W, Colleoni M, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Di Lauro V, Gomez HL, Ruhstaller T, Abdi E, Biganzoli L, Muller B, Barbeaux A, Graas MP, Rabaglio M, Francis PA, Foukakis T, Pagani O, Graiff C, Vorobiof D, Maibach R, Di Leo A, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J; SOLE Investigators. Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. Br J Cancer. 2019 May;120(10):959-967. doi: 10.1038/s41416-019-0435-4. Epub 2019 Apr 10.'}], 'seeAlsoLinks': [{'url': 'http://www.ifct.fr', 'label': 'Official website'}]}, 'descriptionModule': {'briefSummary': 'Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.', 'detailedDescription': 'A phase II trial associating the reference chemotherapy (pemetrexed plus cisplatin) with bevacizumab is needed to ensure that no specific toxicity is induced by this association, and that this triplet have interesting activity. As pleural mesothélioma is a rare tumor, a phase III trial, using the survival data from the phase II part study, will be able to include a sufficient number of patients, in a reasonable period of time, to answer the question of efficacy of the anti-angiogenic triplet, providing the efficacy outcomes could be considered as favorable, at the end of the phase II part of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Malignant, histologically proved, non resectable pleural Mesothelioma\n* In case of pleural effusion, a talc pleurodesis, although not recommended, is allowed in accordance with current local practice, at the time of diagnostic thorascopy, with inclusion CT scan performed after pleurodesis.\n* ECOG Performance status 0-2\n* Mesothelioma with only pleural effusion without uni- or bidimensionally measurable disease will be eligible (adapted RECIST criteria)\n* At least 18 years of age, less than 76 years of age\n* Radiation therapy of thoracocentis tract (3 x 7Gy) performed before beginning medical study treatment, and the interval between thoracoscopic procedure and radiation will not exceed 28 days\n\nExclusion Criteria:\n\n* Prior chemotherapy\n* Brain metastasis\n* History of cerebral vascular accident (CVA) or transient ischemic attack'}, 'identificationModule': {'nctId': 'NCT00651456', 'acronym': 'MAPS', 'briefTitle': 'Mesothelioma Avastin Plus Pemetrexed-cisplatin Study', 'organization': {'class': 'OTHER', 'fullName': 'Intergroupe Francophone de Cancerologie Thoracique'}, 'officialTitle': 'A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)', 'orgStudyIdInfo': {'id': 'IFCT-GFPC-0701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Standard Chemotherapy', 'interventionNames': ['Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Standard Chemotherapy + bevacizumab (Avastin)', 'interventionNames': ['Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab']}], 'interventions': [{'name': 'Standard Chemotherapy (Pemetrexed and Cisplatin)', 'type': 'DRUG', 'description': '* Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation Day 1 (D1=D22, 6 cycles)\n* Cisplatin 75 mg/m² Day 1 (D1=D22, 6 cycles)', 'armGroupLabels': ['1']}, {'name': 'Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab', 'type': 'DRUG', 'description': '* Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation D1 (D1=D22, 6 cycles)\n* Cisplatin 75 mg/m2 D1 (D1=D22, 6 cycles)\n* Bevacizumab 15 mg/kg D1 (D1=D22, until progression)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aix-en-Provence', 'country': 'France', 'facility': "Centre Hospitalier du Pays d'Aix", 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '74100', 'city': 'Ambilly', 'country': 'France', 'facility': 'Annemasse - CH', 'geoPoint': {'lat': 46.1952, 'lon': 6.2243}}, {'city': 'Amiens', 'country': 'France', 'facility': 'Amiens - CHU', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Amiens', 'country': 'France', 'facility': "Clinique de l'Europe", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'Angers - CHU', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '89011', 'city': 'Auxerre', 'country': 'France', 'facility': 'Auxerre - CH', 'geoPoint': {'lat': 47.7996, 'lon': 3.57033}}, {'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU Besancon - Pneumologie', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '34525', 'city': 'Béziers', 'country': 'France', 'facility': 'Béziers - CH', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'zip': '93000', 'city': 'Bobigny', 'country': 'France', 'facility': 'Bobigny - Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'city': 'Bois-Guillaume', 'country': 'France', 'facility': 'Bois-Guillaume - 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CHI', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse - Pneumologie', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'Tours - CHU', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Valence', 'country': 'France', 'facility': 'CH Valence', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}, {'zip': '59304', 'city': 'Valenciennes', 'country': 'France', 'facility': 'Valenciennes - Clinique', 'geoPoint': {'lat': 50.35909, 'lon': 3.52506}}, {'city': 'Vesoul', 'country': 'France', 'facility': 'CHI de la Haute-Saône - Pneumologie', 'geoPoint': {'lat': 47.62604, 'lon': 6.14251}}, {'city': 'Villefranche', 'country': 'France', 'facility': 'CH de Villefranche - Pneumologie', 'geoPoint': {'lat': 47.93333, 'lon': 3.13333}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Gilles Robinet, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GFPC'}, {'name': 'Arnaud Scherpereel, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Intergroupe Francophone de Cancerologie Thoracique'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intergroupe Francophone de Cancerologie Thoracique', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Caen', 'class': 'OTHER'}, {'name': 'Groupe Francais De Pneumo-Cancerologie', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}