Mesothelioma Avastin Plus Pemetrexed-cisplatin Study

Mesothelioma Clinical Trial

— MAPS  

Official title:

A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00651456
• Other study ID #: IFCT-GFPC-0701
• Status: Completed
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Mesothelioma
• Mesothelioma, Malignant

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

External Links

•   Official website