Mesothelioma Avastin Plus Pemetrexed-cisplatin Study

Conditions

Mesothelioma

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.

Levallet G, Creveuil C, Léger-Vigot A, Brosseau S, Danel C, Scherpereel A, Lantuejoul S, Mazières J, Greillier L, Audigier-Valette C, Bergot E, Moro-Sibilot D, Molinier O, Léna H, Monnet I, Morin F, Gounant V, Zalcman G.

2025-09-05

10.1016/j.tranon.2025.102520

Tumor Treating Fields (TTFields) Therapy in Unresectable Pleural Mesothelioma: Overview of Efficacy, Safety, and Future Outlook.

Ceresoli GL, Gianoncelli L.

2025-04-23

10.1007/s11864-025-01320-w

VEGFR2 and CD34 expression associated with longer survival in patients with pleural mesothelioma in the IFCT-GFPC-0701 MAPS phase 3 trial.

Levallet G, Dubois F, Elie N, Creveuil C, Brosseau S, Danel C, Scherpereel A, Lantuejoul S, Mazières J, Greillier L, Audigier-Valette C, Bergot E, Moro-Sibilot D, Molinier O, Léna H, Monnet I, Morin F, Gounant V, Zalcman G.

2023-06-261 citations

10.1016/j.lungcan.2023.107287

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.

Brosseau S, Danel C, Scherpereel A, Mazières 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.

2019-05-1348 citations

10.1016/j.cllc.2019.04.010

Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial.

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, Müller 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.

2019-04-106 citations

10.1038/s41416-019-0435-4

MST1/Hippo promoter gene methylation predicts poor survival in patients with malignant pleural mesothelioma in the IFCT-GFPC-0701 MAPS Phase 3 trial.

Maille E, Brosseau S, Hanoux V, Creveuil C, Danel C, Bergot E, Scherpereel A, Mazières J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Langlais A, Morin F, Levallet G, Zalcman G.

2019-02-1117 citations

10.1038/s41416-019-0379-8

Impact on health-related quality of life of the addition of bevacizumab to cisplatin-pemetrexed in malignant pleural mesothelioma in the MAPS phase III trial.

Virginie Westeel, Guillaume Eberst, Amélie Anota, Arnaud Scherpereel, Julien Mazières et al. (20 authors)

Journal of Clinical Oncology2018-05-203 citations

10.1200/jco.2018.36.15_suppl.8505

Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial.

Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Rivière 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).

2015-12-21666 citations

10.1016/s0140-6736(15)01238-6

Bevacizumab 15mg/kg plus cisplatin-pemetrexed (CP) triplet versus CP doublet in Malignant Pleural Mesothelioma (MPM): Results of the IFCT-GFPC-0701 MAPS randomized phase 3 trial.

Gérard Zalcman, Julien Mazières, J. Margery, Laurent Greillier, Clarisse Audigier-Valette et al. (21 authors)

Journal of Clinical Oncology2015-05-2030 citations

10.1200/jco.2015.33.15_suppl.7500

Interventions

DRUGStandard 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)

DRUGStandard 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

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

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

France

Outcome results

None listed