Mesothelioma Avastin Plus Pemetrexed-cisplatin Study (MAPS)

Intergroupe Francophone de Cancerologie Thoracique

Status and phase: Completed; Phase 3; Phase 2

Conditions: Mesothelioma

Treatments: Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab; Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)

Study type: Interventional

Funder types: Other

Identifiers

NCT00651456

IFCT-GFPC-0701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 448 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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448 participants in 2 patient groups

1

Active Comparator group

Description:

Standard Chemotherapy

Treatment:

Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)

2

Experimental group

Description:

Standard Chemotherapy + bevacizumab (Avastin)

Treatment:

Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab