Mesothelioma Avastin Plus Pemetrexed-cisplatin Study

NCT ID: NCT00651456

Last Updated: 2023-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

448 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mesothelioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Standard Chemotherapy

Group Type ACTIVE_COMPARATOR

Standard Chemotherapy (Pemetrexed and Cisplatin)

Intervention Type DRUG

* 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)

2

Standard Chemotherapy + bevacizumab (Avastin)

Group Type EXPERIMENTAL

Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab

Intervention Type DRUG

* 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)

Interventions

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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)

Intervention Type DRUG

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)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role collaborator

Groupe Francais De Pneumo-Cancerologie

OTHER

Sponsor Role collaborator

Intergroupe Francophone de Cancerologie Thoracique

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles Robinet, Dr

Role: STUDY_DIRECTOR

GFPC

Arnaud Scherpereel, Dr

Role: STUDY_DIRECTOR

Intergroupe Francophone de Cancerologie Thoracique

Locations

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Centre Hospitalier du Pays d'Aix

Aix-en-Provence, , France

Site Status

Annemasse - CH

Ambilly, , France

Site Status

Amiens - CHU

Amiens, , France

Site Status

Clinique de l'Europe

Amiens, , France

Site Status

Angers - CHU

Angers, , France

Site Status

Auxerre - CH

Auxerre, , France

Site Status

CHU Besancon - Pneumologie

Besançon, , France

Site Status

Béziers - CH

Béziers, , France

Site Status

Bobigny - Hôpital Avicenne

Bobigny, , France

Site Status

Bois-Guillaume - CHU

Bois-Guillaume, , France

Site Status

Boujan sur Libron - Polyclinique Saint-Privat

Boujan-sur-Libron, , France

Site Status

Hôpital Ambroise Paré - Pneumologie

Boulogne, , France

Site Status

Brest - CHU

Brest, , France

Site Status

Brest - HIA

Brest, , France

Site Status

Caen - Centre François Baclesse

Caen, , France

Site Status

CHU - Pneumologie

Caen, , France

Site Status

Chauny - CH

Chauny, , France

Site Status

Cherbourg - CH

Cherbourg, , France

Site Status

Hôpital Percy-Armées - Pneumologie

Clamart, , France

Site Status

CHU

Clermont-Ferrand, , France

Site Status

Colmar - CH

Colmar, , France

Site Status

Créteil - CHI

Créteil, , France

Site Status

Denain - CH

Denain, , France

Site Status

Centre Georges François Leclerc

Dijon, , France

Site Status

CHU Hôpital du Bocage

Dijon, , France

Site Status

Elbeuf - CH

Elbeuf, , France

Site Status

Evreux - CH

Évreux, , France

Site Status

Flers - CH

Flers, , France

Site Status

CHU Grenoble - pneumologie

Grenoble, , France

Site Status

Chartres - CH

Le Coudray, , France

Site Status

Centre Hospitalier - Pneumologie

Le Havre, , France

Site Status

Le Havre - HPE

Le Havre, , France

Site Status

Centre Hospitalier - Pneumologie

Le Mans, , France

Site Status

Le Mans - Clinique Victor Hugo

Le Mans, , France

Site Status

CHU (Hôpital Calmette) - Pneumologie

Lille, , France

Site Status

Limoges - Hôpital du Cluzeau

Limoges, , France

Site Status

CH de Longjumeau

Longjumeau, , France

Site Status

Lorient - CHBS

Lorient, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

HCL - Croix-Rousse

Lyon, , France

Site Status

APHM - Hôpital Sainte Marguerite

Marseille, , France

Site Status

Meaux - CH

Meaux, , France

Site Status

Mont de Marsan - CH

Mont-de-Marsan, , France

Site Status

Montpellier - CHRU

Montpellier, , France

Site Status

Mulhouse - CH

Mulhouse, , France

Site Status

CHU

Nancy, , France

Site Status

Nantes - Centre René Gauducheau

Nantes, , France

Site Status

Narbonne - Polyclinique Le Languedoc

Narbonne, , France

Site Status

Nevers - CH

Nevers, , France

Site Status

Nice - CAC

Nice, , France

Site Status

Orléans - CH

Orléans, , France

Site Status

Paray Le Monial - CH

Paray-le-Monial, , France

Site Status

Paray Le Monial - Clinique

Paray-le-Monial, , France

Site Status

Paris - Saint Louis

Paris, , France

Site Status

APHP - Hopital Tenon - Pneumologie

Paris, , France

Site Status

Paris - Curie

Paris, , France

Site Status

Pau - CH

Pau, , France

Site Status

HCL - Lyon Sud (Pneumologie)

Pierre-Bénite, , France

Site Status

CHU

Poitiers, , France

Site Status

Pontoise - CH

Pontoise, , France

Site Status

Reims - CHU

Reims, , France

Site Status

Rennes - CHU

Rennes, , France

Site Status

Roubaix - CH

Roubaix, , France

Site Status

Rouen - CHU

Rouen, , France

Site Status

Saint Brieuc - CHG

Saint-Brieuc, , France

Site Status

Centre Etienne Dolet

Saint-Nazaire, , France

Site Status

Saint-Nazaire - CH

Saint-Nazaire, , France

Site Status

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, , France

Site Status

Saint Quentin - CH

Saint-Quentin, , France

Site Status

Saint-Malo - CH

St-Malo, , France

Site Status

Strasbourg - NHC

Strasbourg, , France

Site Status

Suresnes - Hopital Foch

Suresnes, , France

Site Status

Thonon les bains - CH

Thonon-les-Bains, , France

Site Status

Toulon - CHI

Toulon, , France

Site Status

CHU Toulouse - Pneumologie

Toulouse, , France

Site Status

Tours - CHU

Tours, , France

Site Status

CH Valence

Valence, , France

Site Status

Valenciennes - Clinique

Valenciennes, , France

Site Status

CHI de la Haute-Saône - Pneumologie

Vesoul, , France

Site Status

CH de Villefranche - Pneumologie

Villefranche, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 26719230 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37393757 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31279641 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30967649 (View on PubMed)

Related Links

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http://www.ifct.fr

Official website

Other Identifiers

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IFCT-GFPC-0701

Identifier Type: -

Identifier Source: org_study_id

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