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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 |
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Information provided by: | Intergroupe Francophone de Cancerologie Thoracique |
ClinicalTrials.gov Identifier: | NCT00651456 |
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 |
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Mesothelioma |
Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab |
Phase II Phase III |
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 |
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1: Active Comparator
Standard Chemotherapy
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Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)
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2: Experimental
Standard Chemotherapy + bevacizumab (Avastin)
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Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Gilles Robinet, Dr | GFPC |
Study Director: | Arnaud Scherpereel, Dr | ELCWP |
Responsible Party: | IFCT ( Pr Gérad Zalcman ) |
Study ID Numbers: | IFCT-GFPC-ELCWP-0701 |
Study First Received: | March 29, 2008 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00651456 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Antimetabolites Vitamin B Complex Hydroxocobalamin Vitamin B 12 Bevacizumab Folic Acid Antagonists Angiogenesis Inhibitors Folic Acid |
Pemetrexed Cisplatin Radiation-Sensitizing Agents Vitamins Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Bevacizumab Folic Acid Antagonists Angiogenesis Inhibitors |
Pharmacologic Actions Pemetrexed Neoplasms Cisplatin Radiation-Sensitizing Agents Therapeutic Uses Mesothelioma Growth Inhibitors Angiogenesis Modulating Agents Adenoma Neoplasms, Glandular and Epithelial |