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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00651456
Other study ID # IFCT-GFPC-0701
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date February 2008
Est. completion date September 2016

Study information

Verified date March 2023
Source Intergroupe Francophone de Cancerologie Thoracique
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 448
Est. completion date September 2016
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Malignant, histologically proved, non resectable pleural Mesothelioma - 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. - ECOG Performance status 0-2 - Mesothelioma with only pleural effusion without uni- or bidimensionally measurable disease will be eligible (adapted RECIST criteria) - At least 18 years of age, less than 76 years of age - 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 Exclusion Criteria: - Prior chemotherapy - Brain metastasis - History of cerebral vascular accident (CVA) or transient ischemic attack

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Standard Chemotherapy (Pemetrexed and Cisplatin)
Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation Day 1 (D1=D22, 6 cycles) Cisplatin 75 mg/m² Day 1 (D1=D22, 6 cycles)
Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation D1 (D1=D22, 6 cycles) Cisplatin 75 mg/m2 D1 (D1=D22, 6 cycles) Bevacizumab 15 mg/kg D1 (D1=D22, until progression)

Locations

Country Name City State
France Centre Hospitalier du Pays d'Aix Aix-en-Provence
France Annemasse - CH Ambilly
France Amiens - CHU Amiens
France Clinique de l'Europe Amiens
France Angers - CHU Angers
France Auxerre - CH Auxerre
France CHU Besancon - Pneumologie Besancon
France Béziers - CH Béziers
France Bobigny - Hôpital Avicenne Bobigny
France Bois-Guillaume - CHU Bois-Guillaume
France Boujan sur Libron - Polyclinique Saint-Privat Boujan sur Libron
France Hôpital Ambroise Paré - Pneumologie Boulogne
France Brest - CHU Brest
France Brest - HIA Brest
France Caen - Centre François Baclesse Caen
France CHU - Pneumologie Caen
France Chauny - CH Chauny
France Cherbourg - CH Cherbourg
France Hôpital Percy-Armées - Pneumologie Clamart
France CHU Clermont-Ferrand
France Colmar - CH Colmar
France Créteil - CHI Créteil
France Denain - CH Denain
France Centre Georges François Leclerc Dijon
France CHU Hôpital du Bocage Dijon
France Elbeuf - CH Elbeuf
France Evreux - CH Evreux
France Flers - CH Flers
France CHU Grenoble - pneumologie Grenoble
France Chartres - CH Le Coudray
France Centre Hospitalier - Pneumologie Le Havre
France Le Havre - HPE Le Havre
France Centre Hospitalier - Pneumologie Le Mans
France Le Mans - Clinique Victor Hugo Le Mans
France CHU (Hôpital Calmette) - Pneumologie Lille
France Limoges - Hôpital du Cluzeau Limoges
France CH de Longjumeau Longjumeau
France Lorient - CHBS Lorient
France Centre Léon Bérard Lyon
France HCL - Croix-Rousse Lyon
France APHM - Hôpital Sainte Marguerite Marseille
France Meaux - CH Meaux
France Mont de Marsan - CH Mont de Marsan
France Montpellier - CHRU Montpellier
France Mulhouse - CH Mulhouse
France CHU Nancy
France Nantes - Centre René Gauducheau Nantes
France Narbonne - Polyclinique Le Languedoc Narbonne
France Nevers - CH Nevers
France Nice - CAC Nice
France Orléans - CH Orléans
France Paray Le Monial - CH Paray Le Monial
France Paray Le Monial - Clinique Paray Le Monial
France APHP - Hopital Tenon - Pneumologie Paris
France Paris - Curie Paris
France Paris - Saint Louis Paris
France Pau - CH Pau
France HCL - Lyon Sud (Pneumologie) Pierre Bénite
France CHU Poitiers
France Pontoise - CH Pontoise
France Reims - CHU Reims
France Rennes - CHU Rennes
France Roubaix - CH Roubaix
France Rouen - CHU Rouen
France Saint Brieuc - CHG Saint Brieuc
France Institut de Cancérologie de la Loire Saint Priest en Jarez
France Saint Quentin - CH Saint Quentin
France Saint-Malo - CH Saint-Malo
France Centre Etienne Dolet Saint-Nazaire
France Saint-Nazaire - CH Saint-Nazaire
France Strasbourg - NHC Strasbourg
France Suresnes - Hopital Foch Suresnes
France Thonon les bains - CH Thonon les bains
France Toulon - CHI Toulon
France CHU Toulouse - Pneumologie Toulouse
France Tours - CHU Tours
France CH Valence Valence
France Valenciennes - Clinique Valenciennes
France CHI de la Haute-Saône - Pneumologie Vesoul
France CH de Villefranche - Pneumologie Villefranche
France Institut Gustave Roussy Villejuif

Sponsors (3)

Lead Sponsor Collaborator
Intergroupe Francophone de Cancerologie Thoracique Groupe Francais De Pneumo-Cancerologie, University Hospital, Caen

Country where clinical trial is conducted

France, 

References & Publications (1)

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; Frenc — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Medico-economic assessments of drugs (direct/indirect costs) 3-month
Primary % of patients with controled disease (responder and stable patients) at 6 months 3-month
Secondary Overall Survival month
Secondary Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 month
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