Clinical Trial Phase: Phase 2/Phase 3 Start Date: February 2008
Overall Status: Recruiting
Estimated Enrollment: 445

Rationale

Official Title: “A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)”

Condition Keyword(s): Mesothelioma

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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Detailed Clinical Trial 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.

Outcome Measures for this Clinical Trial

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

Secondary: Overall Survival month

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

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: Intergroupe Francophone de Cancerologie Thoracique
Institut Jules Bordet
BRUXELLES 1000 Belgium
APHP - Hopital Tenon - Pneumologie
PARIS 75020 France

Overall Clinical Trial Officials and Contacts
Gilles Robinet, Dr Study Director GFPC

Overall Contact: Gérard Zalcman, Pr 33-2-31-06-44-76

References

Porret E, Madelaine J, Galateau-Sallé F, Bergot E, Zalcman G. [Epidemiology, molecular biology, diagnostic and therapeutic strategy of malignant pleural mesothelioma in 2007 - an update] Rev Mal Respir. 2007 Oct;24(8 Pt 2):6S157-64. French.

Additional Information

Information obtained from ClinicalTrials.gov on April 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00651456
Study ID Number: IFCT-GFPC-ELCWP-0701
ClinicalTrials.gov Identifier: NCT00651456

Labels: ClinicalTrial