Mesothelioma Avastin Plus Pemetrexed-cisplatin Study (MAPS)

March 10, 2023 updated by: Intergroupe Francophone de Cancerologie Thoracique

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

448

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix-en-Provence, France
        • Centre Hospitalier du Pays d'Aix
      • Ambilly, France, 74100
        • Annemasse - CH
      • Amiens, France
        • Amiens - CHU
      • Amiens, France
        • Clinique de l'Europe
      • Angers, France, 49000
        • Angers - CHU
      • Auxerre, France, 89011
        • Auxerre - CH
      • Besancon, France, 25000
        • CHU Besancon - Pneumologie
      • Bobigny, France, 93000
        • BOBIGNY - Hôpital Avicenne
      • Bois-Guillaume, France
        • Bois-Guillaume - CHU
      • Boujan sur Libron, France
        • Boujan sur Libron - Polyclinique Saint-Privat
      • Boulogne, France
        • Hôpital Ambroise Paré - Pneumologie
      • Brest, France
        • Brest - CHU
      • Brest, France
        • Brest - HIA
      • Béziers, France, 34525
        • Béziers - CH
      • Caen, France, 14000
        • Caen - Centre François Baclesse
      • Caen, France, 14000
        • CHU - Pneumologie
      • Chauny, France
        • Chauny - CH
      • Cherbourg, France
        • Cherbourg - CH
      • Clamart, France, 92140
        • Hôpital Percy-Armées - Pneumologie
      • Clermont-Ferrand, France
        • CHU
      • Colmar, France, 68000
        • Colmar - CH
      • Créteil, France, 94000
        • Créteil - CHI
      • Denain, France
        • Denain - CH
      • Dijon, France
        • Centre Georges Francois Leclerc
      • Dijon, France
        • CHU Hôpital du Bocage
      • Elbeuf, France
        • Elbeuf - CH
      • Evreux, France
        • Evreux - CH
      • Flers, France
        • Flers - CH
      • Grenoble, France, 38000
        • CHU Grenoble - pneumologie
      • Le Coudray, France, 28630
        • Chartres - CH
      • Le Havre, France, 76700
        • Le Havre - HPE
      • Le Havre, France, 76600
        • Centre Hospitalier - Pneumologie
      • Le Mans, France, 72000
        • Centre Hospitalier - Pneumologie
      • Le Mans, France
        • Le Mans - Clinique Victor Hugo
      • Lille, France, 59000
        • CHU (Hôpital Calmette) - Pneumologie
      • Limoges, France, 87042
        • Limoges - Hôpital du Cluzeau
      • Longjumeau, France
        • CH de Longjumeau
      • Lorient, France
        • Lorient - CHBS
      • Lyon, France, 69000
        • Centre Leon Berard
      • Lyon, France, 69000
        • HCL - Croix-Rousse
      • Marseille, France, 13000
        • APHM - Hôpital Sainte Marguerite
      • Meaux, France, 77100
        • Meaux - CH
      • Mont de Marsan, France, 40000
        • Mont de Marsan - CH
      • Montpellier, France, 34295
        • Montpellier - CHRU
      • Mulhouse, France, 68000
        • Mulhouse - CH
      • Nancy, France
        • CHU
      • Nantes, France, 44805
        • Nantes - Centre René Gauducheau
      • Narbonne, France
        • Narbonne - Polyclinique Le Languedoc
      • Nevers, France, 58033
        • Nevers - CH
      • Nice, France, 06000
        • Nice - CAC
      • Orléans, France, 45000
        • Orléans - CH
      • Paray Le Monial, France
        • Paray Le Monial - CH
      • Paray Le Monial, France
        • Paray Le Monial - Clinique
      • Paris, France, 75000
        • Paris - Saint Louis
      • Paris, France, 75020
        • APHP - Hopital Tenon - Pneumologie
      • Paris, France
        • Paris - Curie
      • Pau, France, 64046
        • Pau - CH
      • Pierre Bénite, France, 69495
        • HCL - Lyon Sud (Pneumologie)
      • Poitiers, France
        • CHU
      • Pontoise, France
        • Pontoise - CH
      • Reims, France, 51092
        • Reims - CHU
      • Rennes, France, 35033
        • Rennes - CHU
      • Roubaix, France, 59100
        • Roubaix - CH
      • Rouen, France, 76000
        • Rouen - CHU
      • Saint Brieuc, France, 22000
        • Saint Brieuc - CHG
      • Saint Priest en Jarez, France
        • Institut de Cancerologie de La Loire
      • Saint Quentin, France, 02100
        • Saint Quentin - CH
      • Saint-Malo, France, 35403
        • Saint-Malo - CH
      • Saint-Nazaire, France
        • Saint-Nazaire - CH
      • Saint-Nazaire, France
        • Centre Etienne DOLET
      • Strasbourg, France, 63000
        • Strasbourg - NHC
      • Suresnes, France, 92151
        • Suresnes - Hopital Foch
      • Thonon les bains, France, 74200
        • Thonon les bains - CH
      • Toulon, France, 83000
        • Toulon - CHI
      • Toulouse, France
        • CHU Toulouse - Pneumologie
      • Tours, France, 37000
        • Tours - CHU
      • Valence, France
        • CH Valence
      • Valenciennes, France, 59304
        • Valenciennes - Clinique
      • Vesoul, France
        • CHI de la Haute-Saône - Pneumologie
      • Villefranche, France
        • CH de Villefranche - Pneumologie
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Standard Chemotherapy
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)
Experimental: 2
Standard Chemotherapy + bevacizumab (Avastin)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
% of patients with controled disease (responder and stable patients) at 6 months
Time Frame: 3-month
3-month

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: month
month
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
Time Frame: month
month

Other Outcome Measures

Outcome Measure
Time Frame
Medico-economic assessments of drugs (direct/indirect costs)
Time Frame: 3-month
3-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Collaborators

University Hospital, Caen
Groupe Francais De Pneumo-Cancerologie

Investigators

  • Study Director: Gilles Robinet, Dr, GFPC
  • Study Director: Arnaud Scherpereel, Dr, Intergroupe Francophone de Cancerologie Thoracique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

March 29, 2008

First Submitted That Met QC Criteria

April 1, 2008

First Posted (Estimate)

April 2, 2008

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFCT-GFPC-0701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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