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| Sponsors and Collaborators: |
Intergroupe Francophone de Cancerologie Thoracique CHU de Caen Groupe Francais de Pneumo-Cancérologie European Lung Cancer Working Party |
| Information provided by: | Intergroupe Francophone de Cancerologie Thoracique |
| ClinicalTrials.gov Identifier: | NCT00651456 |
Purpose
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.
| Condition | Intervention | Phase |
|
Mesothelioma |
Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab |
Phase II Phase III |
| MedlinePlus related topics: | Mesothelioma |
| Drug Information available for: | Cisplatin Pemetrexed disodium Pemetrexed Folic acid Vitamin B 12 Hydroxocobalamin Bevacizumab |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM) |
| Estimated Enrollment: | 445 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Active Comparator
Standard Chemotherapy
|
Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)
|
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2: Experimental
Standard Chemotherapy + bevacizumab (Avastin)
|
Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
|
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Gérard Zalcman, Pr | 33-2-31-06-44-76 | |
| Contact: Franck Morin | franck.morin@ifct.fr |
| Belgium | |||||
| Institut Jules Bordet | Recruiting | ||||
| BRUXELLES, Belgium, 1000 | |||||
| Contact: Thierry Berghmans, Dr +32 25 41 31 11 | |||||
| France | |||||
| APHP - Hopital Tenon - Pneumologie | Recruiting | ||||
| PARIS, France, 75020 | |||||
| Contact: Bernard MILLERON, Dr | |||||
| Centre Hospitalier - Pneumologie | Recruiting | ||||
| Belfort, France, 90016 | |||||
| Contact: Jean-Luc Breton, Dr +33 3 84 98 51 18 | |||||
| CHU - Pneumologie | Recruiting | ||||
| CAEN, France, 14000 | |||||
| Contact: Gerard Zalcman, Pr | |||||
| CHU Besancon - Pneumologie | Recruiting | ||||
| Besancon, France, 25000 | |||||
| Contact: Pascale Jacoulet, Dr | |||||
| CHU Grenoble - pneumologie | Recruiting | ||||
| Grenoble, France, 38000 | |||||
| Contact: Denis Moro-Sibilot, Pr | |||||
| Principal Investigator: Denis Moro-Sibilot, Pr | |||||
| CHU Lyautey - Pneumologie | Recruiting | ||||
| Strasbourg, France, 63000 | |||||
| Contact: Elisabeth Quoix, Pr | |||||
| Principal Investigator: Elisabeth Quoix, Pr | |||||
| Institut Gustave Roussy | Recruiting | ||||
| VILLEJUIF, France, 94805 | |||||
| Contact: Pierre Ruffié, Dr +33 1 42 11 42 11 | |||||
| CHU (Hôpital Calmette) - Pneumologie | Recruiting | ||||
| Lille, France, 59000 | |||||
| Contact: Arnaud Scherpereel, Dr | |||||
| HCL - Croix-Rousse | Recruiting | ||||
| LYON, France, 69000 | |||||
| Contact: Maurice Pérol, Dr | |||||
| HCL - Lyon Sud (Pneumologie) | Recruiting | ||||
| Pierre Bénite, France, 69495 | |||||
| Contact: Pierre-Jean Souquet, Dr | |||||
| CHU Toulouse - Pneumologie | Recruiting | ||||
| Toulouse, France | |||||
| Contact: Julien Mazieres, Pr | |||||
| Hôpital Percy-Armées - Pneumologie | Recruiting | ||||
| Clamart, France, 92140 | |||||
| Contact: Jacques Margery, Dr | |||||
| Centre Hospitalier - Pneumologie | Recruiting | ||||
| Le Havre, France, 76600 | |||||
| Contact: Philippe Hubscher, Dr | |||||
| Centre Hospitalier - Pneumologie | Recruiting | ||||
| Le Mans, France, 72000 | |||||
| Contact: Francois-Xavier Lebas, Dr | |||||
| Contact: Olivier Molinier, Dr | |||||
| APHM - Hôpital Sainte Marguerite | Recruiting | ||||
| Marseille, France, 13000 | |||||
| Contact: Philippe ASTOUL, Pr | |||||
| Intergroupe Francophone de Cancerologie Thoracique |
| CHU de Caen |
| Groupe Francais de Pneumo-Cancérologie |
| European Lung Cancer Working Party |
| Study Director: | Gilles Robinet, Dr | GFPC |
| Study Director: | Arnaud Scherpereel, Dr | ELCWP |
More Information
Official website 
  |
| Responsible Party: | IFCT ( Pr Gérad Zalcman ) |
| Study ID Numbers: | IFCT-GFPC-ELCWP-0701 |
| First Received: | March 29, 2008 |
| Last Updated: | April 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00651456 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
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