Mesothelioma Avastin Plus Pemetrexed-cisplatin Study
MAPS
A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)
1 other identifier
interventional
448
1 country
81
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2008
Longer than P75 for phase_2
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 29, 2008
CompletedFirst Posted
Study publicly available on registry
April 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedMarch 13, 2023
March 1, 2023
6.9 years
March 29, 2008
March 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
% of patients with controled disease (responder and stable patients) at 6 months
3-month
Secondary Outcomes (2)
Overall Survival
month
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
month
Other Outcomes (1)
Medico-economic assessments of drugs (direct/indirect costs)
3-month
Study Arms (2)
1
ACTIVE COMPARATORStandard Chemotherapy
2
EXPERIMENTALStandard Chemotherapy + bevacizumab (Avastin)
Interventions
* 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)
* 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)
Eligibility Criteria
You may qualify if:
- Malignant, histologically proved, non resectable pleural Mesothelioma
- 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
You may not qualify if:
- Prior chemotherapy
- Brain metastasis
- History of cerebral vascular accident (CVA) or transient ischemic attack
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France
Annemasse - CH
Ambilly, 74100, France
Amiens - CHU
Amiens, France
Clinique de l'Europe
Amiens, France
Angers - CHU
Angers, 49000, France
Auxerre - CH
Auxerre, 89011, France
CHU Besancon - Pneumologie
Besançon, 25000, France
Béziers - CH
Béziers, 34525, France
Bobigny - Hôpital Avicenne
Bobigny, 93000, 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, 14000, France
CHU - Pneumologie
Caen, 14000, France
Chauny - CH
Chauny, France
Cherbourg - CH
Cherbourg, France
Hôpital Percy-Armées - Pneumologie
Clamart, 92140, France
CHU
Clermont-Ferrand, France
Colmar - CH
Colmar, 68000, France
Créteil - CHI
Créteil, 94000, France
Denain - CH
Denain, France
Centre Georges François Leclerc
Dijon, France
CHU Hôpital du Bocage
Dijon, France
Elbeuf - CH
Elbeuf, France
Evreux - CH
Évreux, France
Flers - CH
Flers, France
CHU Grenoble - pneumologie
Grenoble, 38000, France
Chartres - CH
Le Coudray, 28630, France
Centre Hospitalier - Pneumologie
Le Havre, 76600, France
Le Havre - HPE
Le Havre, 76700, France
Centre Hospitalier - Pneumologie
Le Mans, 72000, France
Le Mans - Clinique Victor Hugo
Le Mans, France
CHU (Hôpital Calmette) - Pneumologie
Lille, 59000, France
Limoges - Hôpital du Cluzeau
Limoges, 87042, France
CH de Longjumeau
Longjumeau, France
Lorient - CHBS
Lorient, France
Centre Léon Bérard
Lyon, 69000, France
HCL - Croix-Rousse
Lyon, 69000, France
APHM - Hôpital Sainte Marguerite
Marseille, 13000, France
Meaux - CH
Meaux, 77100, France
Mont de Marsan - CH
Mont-de-Marsan, 40000, France
Montpellier - CHRU
Montpellier, 34295, France
Mulhouse - CH
Mulhouse, 68000, France
CHU
Nancy, France
Nantes - Centre René Gauducheau
Nantes, 44805, France
Narbonne - Polyclinique Le Languedoc
Narbonne, France
Nevers - CH
Nevers, 58033, France
Nice - CAC
Nice, 06000, France
Orléans - CH
Orléans, 45000, France
Paray Le Monial - CH
Paray-le-Monial, France
Paray Le Monial - Clinique
Paray-le-Monial, France
Paris - Saint Louis
Paris, 75000, France
APHP - Hopital Tenon - Pneumologie
Paris, 75020, France
Paris - Curie
Paris, France
Pau - CH
Pau, 64046, France
HCL - Lyon Sud (Pneumologie)
Pierre-Bénite, 69495, France
CHU
Poitiers, France
Pontoise - CH
Pontoise, France
Reims - CHU
Reims, 51092, France
Rennes - CHU
Rennes, 35033, France
Roubaix - CH
Roubaix, 59100, France
Rouen - CHU
Rouen, 76000, France
Saint Brieuc - CHG
Saint-Brieuc, 22000, France
Centre Etienne Dolet
Saint-Nazaire, France
Saint-Nazaire - CH
Saint-Nazaire, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, France
Saint Quentin - CH
Saint-Quentin, 02100, France
Saint-Malo - CH
St-Malo, 35403, France
Strasbourg - NHC
Strasbourg, 63000, France
Suresnes - Hopital Foch
Suresnes, 92151, France
Thonon les bains - CH
Thonon-les-Bains, 74200, France
Toulon - CHI
Toulon, 83000, France
CHU Toulouse - Pneumologie
Toulouse, France
Tours - CHU
Tours, 37000, France
CH Valence
Valence, France
Valenciennes - Clinique
Valenciennes, 59304, France
CHI de la Haute-Saône - Pneumologie
Vesoul, France
CH de Villefranche - Pneumologie
Villefranche, France
Institut Gustave Roussy
Villejuif, 94805, France
Related Publications (4)
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.
PMID: 26719230RESULTLevallet 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.
PMID: 37393757DERIVEDBrosseau 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.
PMID: 31279641DERIVEDRibi 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.
PMID: 30967649DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilles Robinet, Dr
GFPC
- STUDY DIRECTOR
Arnaud Scherpereel, Dr
Intergroupe Francophone de Cancerologie Thoracique
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2008
First Posted
April 2, 2008
Study Start
February 1, 2008
Primary Completion
January 1, 2015
Study Completion
September 1, 2016
Last Updated
March 13, 2023
Record last verified: 2023-03