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Mesothelioma Avastin Plus Pemetrexed-cisplatin Study (MAPS)

Primary Purpose

Mesothelioma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Standard Chemotherapy (Pemetrexed and Cisplatin)
Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
Sponsored by
Intergroupe Francophone de Cancerologie Thoracique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mesothelioma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Standard Chemotherapy

Standard Chemotherapy + bevacizumab (Avastin)

Outcomes

Primary Outcome Measures

% of patients with controled disease (responder and stable patients) at 6 months

Secondary Outcome Measures

Overall Survival
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0

Full Information

First Posted
March 29, 2008
Last Updated
March 10, 2023
Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Collaborators
University Hospital, Caen, Groupe Francais De Pneumo-Cancerologie
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1. Study Identification

Unique Protocol Identification Number
NCT00651456
Brief Title
Mesothelioma Avastin Plus Pemetrexed-cisplatin Study
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Collaborators
University Hospital, Caen, Groupe Francais De Pneumo-Cancerologie

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
448 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Standard Chemotherapy
Arm Title
2
Arm Type
Experimental
Arm Description
Standard Chemotherapy + bevacizumab (Avastin)
Intervention Type
Drug
Intervention Name(s)
Standard Chemotherapy (Pemetrexed and Cisplatin)
Intervention Description
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
Intervention Name(s)
Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
Intervention Description
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)
Primary Outcome Measure Information:
Title
% of patients with controled disease (responder and stable patients) at 6 months
Time Frame
3-month
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
month
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
Time Frame
month
Other Pre-specified Outcome Measures:
Title
Medico-economic assessments of drugs (direct/indirect costs)
Time Frame
3-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Robinet, Dr
Organizational Affiliation
GFPC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Arnaud Scherpereel, Dr
Organizational Affiliation
Intergroupe Francophone de Cancerologie Thoracique
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier du Pays d'Aix
City
Aix-en-Provence
Country
France
Facility Name
Annemasse - CH
City
Ambilly
ZIP/Postal Code
74100
Country
France
Facility Name
Amiens - CHU
City
Amiens
Country
France
Facility Name
Clinique de l'Europe
City
Amiens
Country
France
Facility Name
Angers - CHU
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Auxerre - CH
City
Auxerre
ZIP/Postal Code
89011
Country
France
Facility Name
CHU Besancon - Pneumologie
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Bobigny - Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Bois-Guillaume - CHU
City
Bois-Guillaume
Country
France
Facility Name
Boujan sur Libron - Polyclinique Saint-Privat
City
Boujan sur Libron
Country
France
Facility Name
Hôpital Ambroise Paré - Pneumologie
City
Boulogne
Country
France
Facility Name
Brest - CHU
City
Brest
Country
France
Facility Name
Brest - HIA
City
Brest
Country
France
Facility Name
Béziers - CH
City
Béziers
ZIP/Postal Code
34525
Country
France
Facility Name
Caen - Centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CHU - Pneumologie
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Chauny - CH
City
Chauny
Country
France
Facility Name
Cherbourg - CH
City
Cherbourg
Country
France
Facility Name
Hôpital Percy-Armées - Pneumologie
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
CHU
City
Clermont-Ferrand
Country
France
Facility Name
Colmar - CH
City
Colmar
ZIP/Postal Code
68000
Country
France
Facility Name
Créteil - CHI
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Denain - CH
City
Denain
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
Country
France
Facility Name
CHU Hôpital du Bocage
City
Dijon
Country
France
Facility Name
Elbeuf - CH
City
Elbeuf
Country
France
Facility Name
Evreux - CH
City
Evreux
Country
France
Facility Name
Flers - CH
City
Flers
Country
France
Facility Name
CHU Grenoble - pneumologie
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Chartres - CH
City
Le Coudray
ZIP/Postal Code
28630
Country
France
Facility Name
Centre Hospitalier - Pneumologie
City
Le Havre
ZIP/Postal Code
76600
Country
France
Facility Name
Le Havre - HPE
City
Le Havre
ZIP/Postal Code
76700
Country
France
Facility Name
Centre Hospitalier - Pneumologie
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Le Mans - Clinique Victor Hugo
City
Le Mans
Country
France
Facility Name
CHU (Hôpital Calmette) - Pneumologie
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Limoges - Hôpital du Cluzeau
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CH de Longjumeau
City
Longjumeau
Country
France
Facility Name
Lorient - CHBS
City
Lorient
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
HCL - Croix-Rousse
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
APHM - Hôpital Sainte Marguerite
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Meaux - CH
City
Meaux
ZIP/Postal Code
77100
Country
France
Facility Name
Mont de Marsan - CH
City
Mont de Marsan
ZIP/Postal Code
40000
Country
France
Facility Name
Montpellier - CHRU
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Mulhouse - CH
City
Mulhouse
ZIP/Postal Code
68000
Country
France
Facility Name
CHU
City
Nancy
Country
France
Facility Name
Nantes - Centre René Gauducheau
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Narbonne - Polyclinique Le Languedoc
City
Narbonne
Country
France
Facility Name
Nevers - CH
City
Nevers
ZIP/Postal Code
58033
Country
France
Facility Name
Nice - CAC
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Orléans - CH
City
Orléans
ZIP/Postal Code
45000
Country
France
Facility Name
Paray Le Monial - CH
City
Paray Le Monial
Country
France
Facility Name
Paray Le Monial - Clinique
City
Paray Le Monial
Country
France
Facility Name
Paris - Saint Louis
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Name
APHP - Hopital Tenon - Pneumologie
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Paris - Curie
City
Paris
Country
France
Facility Name
Pau - CH
City
Pau
ZIP/Postal Code
64046
Country
France
Facility Name
HCL - Lyon Sud (Pneumologie)
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU
City
Poitiers
Country
France
Facility Name
Pontoise - CH
City
Pontoise
Country
France
Facility Name
Reims - CHU
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Rennes - CHU
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Roubaix - CH
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Rouen - CHU
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Saint Brieuc - CHG
City
Saint Brieuc
ZIP/Postal Code
22000
Country
France
Facility Name
Institut de Cancérologie de la Loire
City
Saint Priest en Jarez
Country
France
Facility Name
Saint Quentin - CH
City
Saint Quentin
ZIP/Postal Code
02100
Country
France
Facility Name
Saint-Malo - CH
City
Saint-Malo
ZIP/Postal Code
35403
Country
France
Facility Name
Centre Etienne Dolet
City
Saint-Nazaire
Country
France
Facility Name
Saint-Nazaire - CH
City
Saint-Nazaire
Country
France
Facility Name
Strasbourg - NHC
City
Strasbourg
ZIP/Postal Code
63000
Country
France
Facility Name
Suresnes - Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Thonon les bains - CH
City
Thonon les bains
ZIP/Postal Code
74200
Country
France
Facility Name
Toulon - CHI
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
CHU Toulouse - Pneumologie
City
Toulouse
Country
France
Facility Name
Tours - CHU
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
CH Valence
City
Valence
Country
France
Facility Name
Valenciennes - Clinique
City
Valenciennes
ZIP/Postal Code
59304
Country
France
Facility Name
CHI de la Haute-Saône - Pneumologie
City
Vesoul
Country
France
Facility Name
CH de Villefranche - Pneumologie
City
Villefranche
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26719230
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. Erratum In: Lancet. 2016 Apr 2;387(10026):e24.
Results Reference
result
PubMed Identifier
31279641
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.
Results Reference
derived
PubMed Identifier
30967649
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. Erratum In: Br J Cancer. 2020 Jan 16;:
Results Reference
derived
Links:
URL
http://www.ifct.fr
Description
Official website

Learn more about this trial

Mesothelioma Avastin Plus Pemetrexed-cisplatin Study

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