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MesotheliomaPhase 2/3MAPSNCT00651456

Mesothelioma Avastin Plus Pemetrexed-cisplatin Study

A Phase 2/3 study testing Standard Chemotherapy (Pemetrexed and Cisplatin) and Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab in people with Mesothelioma, run by Intergroupe Francophone de Cancerologie Thoracique at 81 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Mesothelioma
What is being tested?
Standard Chemotherapy (Pemetrexed and Cisplatin) and Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
448 participants
Where
81 sitesFrance
Study dates
Feb 2008to Sep 2016
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Prior chemotherapy
  • Brain metastasis
  • History of cerebral vascular accident (CVA) or transient ischemic attack

Trial locations and contacts

81 sites in 1 country.

81 sites in 1 country

France81 sites

  • Centre Hospitalier du Pays d'Aix

    Aix-en-Provence

  • Annemasse - CH

    Ambilly, 74100

  • Amiens - CHU

    Amiens

  • Clinique de l'Europe

    Amiens

  • Angers - CHU

    Angers, 49000

  • Auxerre - CH

    Auxerre, 89011

  • CHU Besancon - Pneumologie

    Besançon, 25000

  • Béziers - CH

    Béziers, 34525

  • Bobigny - Hôpital Avicenne

    Bobigny, 93000

  • Bois-Guillaume - CHU

    Bois-Guillaume

  • Boujan sur Libron - Polyclinique Saint-Privat

    Boujan-sur-Libron

  • Hôpital Ambroise Paré - Pneumologie

    Boulogne

  • Brest - CHU

    Brest

  • Brest - HIA

    Brest

  • Caen - Centre François Baclesse

    Caen, 14000

  • CHU - Pneumologie

    Caen, 14000

  • Chauny - CH

    Chauny

  • Cherbourg - CH

    Cherbourg

  • Hôpital Percy-Armées - Pneumologie

    Clamart, 92140

  • CHU

    Clermont-Ferrand

  • Colmar - CH

    Colmar, 68000

  • Créteil - CHI

    Créteil, 94000

  • Denain - CH

    Denain

  • Centre Georges François Leclerc

    Dijon

  • CHU Hôpital du Bocage

    Dijon

  • Elbeuf - CH

    Elbeuf

  • Evreux - CH

    Évreux

  • Flers - CH

    Flers

  • CHU Grenoble - pneumologie

    Grenoble, 38000

  • Chartres - CH

    Le Coudray, 28630

  • Centre Hospitalier - Pneumologie

    Le Havre, 76600

  • Le Havre - HPE

    Le Havre, 76700

  • Centre Hospitalier - Pneumologie

    Le Mans, 72000

  • Le Mans - Clinique Victor Hugo

    Le Mans

  • CHU (Hôpital Calmette) - Pneumologie

    Lille, 59000

  • Limoges - Hôpital du Cluzeau

    Limoges, 87042

  • CH de Longjumeau

    Longjumeau

  • Lorient - CHBS

    Lorient

  • Centre Léon Bérard

    Lyon, 69000

  • HCL - Croix-Rousse

    Lyon, 69000

  • APHM - Hôpital Sainte Marguerite

    Marseille, 13000

  • Meaux - CH

    Meaux, 77100

  • Mont de Marsan - CH

    Mont-de-Marsan, 40000

  • Montpellier - CHRU

    Montpellier, 34295

  • Mulhouse - CH

    Mulhouse, 68000

  • CHU

    Nancy

  • Nantes - Centre René Gauducheau

    Nantes, 44805

  • Narbonne - Polyclinique Le Languedoc

    Narbonne

  • Nevers - CH

    Nevers, 58033

  • Nice - CAC

    Nice, 06000

  • Orléans - CH

    Orléans, 45000

  • Paray Le Monial - CH

    Paray-le-Monial

  • Paray Le Monial - Clinique

    Paray-le-Monial

  • Paris - Saint Louis

    Paris, 75000

  • APHP - Hopital Tenon - Pneumologie

    Paris, 75020

  • Paris - Curie

    Paris

  • Pau - CH

    Pau, 64046

  • HCL - Lyon Sud (Pneumologie)

    Pierre-Bénite, 69495

  • CHU

    Poitiers

  • Pontoise - CH

    Pontoise

  • Reims - CHU

    Reims, 51092

  • Rennes - CHU

    Rennes, 35033

  • Roubaix - CH

    Roubaix, 59100

  • Rouen - CHU

    Rouen, 76000

  • Saint Brieuc - CHG

    Saint-Brieuc, 22000

  • Centre Etienne Dolet

    Saint-Nazaire

  • Saint-Nazaire - CH

    Saint-Nazaire

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez

  • Saint Quentin - CH

    Saint-Quentin, 02100

  • Saint-Malo - CH

    St-Malo, 35403

  • Strasbourg - NHC

    Strasbourg, 63000

  • Suresnes - Hopital Foch

    Suresnes, 92151

  • Thonon les bains - CH

    Thonon-les-Bains, 74200

  • Toulon - CHI

    Toulon, 83000

  • CHU Toulouse - Pneumologie

    Toulouse

  • Tours - CHU

    Tours, 37000

  • CH Valence

    Valence

  • Valenciennes - Clinique

    Valenciennes, 59304

  • CHI de la Haute-Saône - Pneumologie

    Vesoul

  • CH de Villefranche - Pneumologie

    Villefranche

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions
Mesothelioma
Being tested
Standard Chemotherapy (Pemetrexed and Cisplatin), Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
Medical subject headings
Mesothelioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Chemotherapy (Pemetrexed and Cisplatin)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)

  • Standard Chemotherapy (Pemetrexed and Cisplatin) + BevacizumabDrug

    • 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)
Study groups in NCT00651456
Study groupRoleWhat they receive
1Active comparatorStandard Chemotherapy
Receives: Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)
2ExperimentalStandard Chemotherapy + bevacizumab (Avastin)
Receives: Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3-month

Secondary outcomes (2)

  1. Overall Survival

    Measured: month

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

    Measured: month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionJan 2015
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
448 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00651456
Sponsor's protocol ID
IFCT-GFPC-0701
Acronym
MAPS
Status last verified
Mar 2023
First submitted
29 Mar 2008
Last updated
13 Mar 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26719230

  • 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.

    PubMed 37393757

  • 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.

    PubMed 31279641

  • 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.

    PubMed 30967649

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Standard Chemotherapy (Pemetrexed and Cisplatin) and Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab in people with Mesothelioma, run by Intergroupe Francophone de Cancerologie Thoracique at 81 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

% of patients with controled disease (responder and stable patients) at 6 months (time frame: 3-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00651456, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.

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