Mesothelioma Avastin Plus Pemetrexed-cisplatin Study

Phase 2

Completed

• Conditions: Mesothelioma
• Interventions: Drug: Standard Chemotherapy (Pemetrexed and Cisplatin); Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab

• Registration Number: NCT00651456
• Lead Sponsor: Intergroupe Francophone de Cancerologie Thoracique

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-29
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-02
• Primary Completion: 2015-01
• Study Completion: 2016-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 448

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Standard Chemotherapy (Pemetrexed and Cisplatin)	Standard Chemotherapy
2	Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab	Standard Chemotherapy + bevacizumab (Avastin)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (78)

Centre Hospitalier du Pays d'Aix; 🇫🇷 Aix-en-Provence, France

Annemasse - CH; 🇫🇷 Ambilly, France

Amiens - CHU; 🇫🇷 Amiens, France

Clinique de l'Europe; 🇫🇷 Amiens, France

Angers - CHU; 🇫🇷 Angers, France

Auxerre - CH; 🇫🇷 Auxerre, France

CHU Besancon - Pneumologie; 🇫🇷 Besancon, France

Bobigny - Hôpital Avicenne; 🇫🇷 Bobigny, France

Bois-Guillaume - CHU; 🇫🇷 Bois-Guillaume, France

Boujan sur Libron - Polyclinique Saint-Privat; 🇫🇷 Boujan sur Libron, France

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