Overview

This trial is active, not recruiting.

Condition mesothelioma
Treatments standard chemotherapy (pemetrexed and cisplatin), standard chemotherapy (pemetrexed and cisplatin) + bevacizumab
Phase phase 2/phase 3
Sponsor Intergroupe Francophone de Cancerologie Thoracique
Collaborator University Hospital, Caen
Start date February 2008
End date January 2015
Trial size 448 participants
Trial identifier NCT00651456, IFCT-GFPC-0701

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Standard Chemotherapy
standard 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)
(Experimental)
Standard Chemotherapy + bevacizumab (Avastin)
standard 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)

Primary Outcomes

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

Secondary Outcomes

Measure
Overall Survival
time frame: month

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Intergroupe Francophone de Cancerologie Thoracique.