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Posted on Saturday, Mar 1, 2008

Mesothelioma Avastin Plus Pemetrexed-Cisplatin Study

Date First Received: March 29, 2008

Last Updated: April 2, 2008

Verified by: Intergroupe Francophone de Cancerologie Thoracique, April 2008

Clinical Trial Phase: Phase 2/Phase 3 | Start Date: February 2008

Overall Status: Recruiting

Estimated Enrollment: 445

Brief Summary

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

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 controlled disease (responder and stable patients) at 6 months 3-month

Secondary:

  • Overall Survival month
  • Criteria for Participation in this Clinical Trial

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

Centre Hospitalier – Pneumologie

Belfort 90016 France

CHU – Pneumologie

CAEN 14000 France

CHU Besancon – Pneumologie

Besancon 25000 France

CHU Grenoble – pneumologie

Grenoble 38000 France

CHU Lyautey – Pneumologie

Strasbourg 63000 France

Institut Gustave Roussy

VILLEJUIF 94805 France

APHM – Hôpital Sainte Marguerite

Marseille 13000 France

HCL – Croix-Rousse

LYON 69000 France

HCL – Lyon Sud (Pneumologie)

Pierre Bénite 69495 France

CHU Toulouse – Pneumologie

Toulouse France

Hôpital Percy-Armées – Pneumologie

Clamart 92140 France

Centre Hospitalier – Pneumologie

Le Havre 76600 France

Centre Hospitalier – Pneumologie

Le Mans 72000 France

CHU (Hôpital Calmette) – Pneumologie

Lille 59000 France

Overall Clinical Trial Officials and Contacts

Gilles Robinet, Dr Study Director GFPC

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

Related Publications

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 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00651456

Study ID Number: IFCT-GFPC-ELCWP-0701

ClinicalTrials.gov Identifier: NCT00651456

Health Authority: France: Afssaps – French Health Products Safety Agency

Clinical Trials Authorship and Review

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.