Mesothelioma Avastin Plus Pemetrexed-cisplatin Study
Groupe Francais de Pneumo-Cancerologie
Trial Sites
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Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III, Phase II | Treatment | Active | 18 to 75 | Other | IFCT-GFPC-0701 NCT00651456 |
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.
Further Study Information
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 Criteria
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
Trial Lead Organizations/Sponsors
French Thoracic Oncology Intergroup Center
CHU de CaenGroupe Francais de Pneumo-Cancerologie
| Gilles Robinet, Dr |  | Study Director |
| Arnaud Scherpereel, Dr | | Study Director |
| Gérard Zalcman, Pr | | Ph: 33-2-31-06-44-76 |
Trial Sites
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| France | |||
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| Aix-en-Provence | |||
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| Centre Hospitalier du Pays d'Aix | |||
| Jacques LE TREUT | |||
| Email: contact@ifct.fr | |||
| Ambilly | |||
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| Centre Hospitalier Annemasse Bonneville | |||
| Patrick CHATELLAIN, Dr | |||
| Amiens | |||
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| Centre Hospitalier Universitaire d'Amiens | |||
| Vincent JOUNIEAUX, Pr | |||
| Clinique de l'Europe | |||
| Olivier CARRE | |||
| Email: contact@ifct.fr | |||
| Angers | |||
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| Centre Hospitalier Regional et Universitaire d'Angers | |||
| Nathalie Baize, Dr | |||
| Auxerre | |||
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| Centre Hospitalier d'Auxerre | |||
| Hubert BARBIEUX, Dr | |||
| Besancon | |||
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| Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz | |||
| Pascale Jacoulet, Dr | |||
| Béziers | |||
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| Hopital de Beziers | |||
| Frédéric GOUTORBE, Dr | |||
| Bobigny | |||
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| Hopital Avicenne | |||
| Jean-Francois MORERE, Pr | |||
| Bois-Guillaume | |||
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| Bois-Guillaume - CHU | |||
| Jean-François MUIR, Pr | |||
| Boujan sur Libron | |||
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| Boujan sur Libron - Polyclinique Saint-Privat | |||
| Michael HUMMELSBERGER, Dr | |||
| Boulogne | |||
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| Hopital Ambroise Pare | |||
| Etienne GIROUX-LEPRIEUR | |||
| Brest | |||
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| Brest - CHU | |||
| Gilles ROBINET, Dr | |||
| Brest - HIA | |||
| Michel André, Dr | |||
| Caen | |||
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| Centre Regional Francois Baclesse | |||
| Alain RIVIERE, Dr | |||
| CHU de Caen | |||
| Gerard Zalcman, Pr | |||
| Chauny | |||
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| Centre Hospitalier de Chauny | |||
| Patrick DUMONT | |||
| Cherbourg | |||
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| Cherbourg - CH | |||
| Laure Kaluzinski, Dr | |||
| Clamart | |||
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| Hopital d'Instruction des Armees Percy | |||
| Jacques Margery, Dr | |||
| Clermont-Ferrand | |||
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| CHR Clermont Ferrand, Hotel Dieu | |||
| Henri JANICOT | |||
| Email: contact@ifct.fr | |||
| Colmar | |||
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| Hopital Louis Pasteur | |||
| Lionel MOREAU, Dr | |||
| Créteil | |||
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| Hopital Intercommunal De Creteil | |||
| Isabelle Monnet, Dr | |||
| Email: contact@ifct.fr | |||
| Denain | |||
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| Centre Hospitalier Denain | |||
| Jean-Pierre Grignet, Dr | |||
| Dijon | |||
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| Centre de Lutte Contre le Cancer Georges-Francois Leclerc | |||
| Bruno COUDERT | |||
| Email: contact@ifct.fr | |||
| Hopital Du Bocage | |||
| Pascale FOUCHER | |||
| Email: contact@ifct.fr | |||
| Elbeuf | |||
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| Centre Hospitalier Intercommunal St. Aubin les Elbeuf | |||
| Pierre-Alexandre HAUSS, Dr | |||
| Evreux | |||
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| Centre Hospitalier D'Evreux | |||
| Jacques BRES, Dr | |||
| Flers | |||
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| Centre Hospitalier de Flers | |||
| Gilles Saucier, Dr | |||
| Grenoble | |||
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| CHU de Grenoble - Hopital de la Tronche | |||
| Denis Moro-Sibilot, Pr | |||
| Denis Moro-Sibilot | Principal Investigator | ||
| Le Coudray | |||
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| Chartres - CH | |||
| Marc Zaegel, Dr | |||
| Le Havre | |||
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| Centre Hospitalier - Pneumologie | |||
| Philippe Hubscher, Dr | |||
| Hopital Prive de l'Estuaire Le Havre | |||
| Jean-Paul Duhamel, Dr | |||
| Le Mans | |||
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| Centre Hospitalier General | |||
| Olivier Molinier, Dr | |||
| Clinique Victor Hugo | |||
| Fabrice DENIS, Dr | |||
| Lille | |||
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| Centre Bourgogne | |||
| Arnaud Scherpereel, Dr | |||
| Limoges | |||
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| Hospital du Cluzeau | |||
| Alain VERGNENEGRE, Pr | |||
| Longjumeau | |||
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| Centre Hospitalier General | |||
| Gérard OLIVIERO | |||
| Email: contact@ifct.fr | |||
| Lorient | |||
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| Centre Hospitalier Bretagne Sud | |||
| Régine LAMY, Dr | |||
| Lyon | |||
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| Centre Leon Berard | |||
| Maurice Pérol, Dr | |||
| Hopital de la Croix Rousse | |||
| Maurice Pérol, Dr | |||
| Marseille | |||
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| Hopital Sainte Marguerite | |||
| Philippe ASTOUL, Pr | |||
| Meaux | |||
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| Centre Hospitalier de Meaux | |||
| Chrystèle Locher, Dr | |||
| Mont de Marsan | |||
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| Centre Hospitalier General de Mont de Marsan | |||
| Jérome Dauba, Dr | |||
| Montpellier | |||
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| Hopital Saint Eloi | |||
| Xavier Quantin, Dr | |||
| Mulhouse | |||
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| Centre Hospitalier de Mulhouse | |||
| Didier DEBIEUVRE, Dr | |||
| Nancy | |||
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| Centre Hospitalier Universitaire de Nancy | |||
| Yves MARTINET, MD, PhD | |||
| Nantes | |||
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| Centre Regional Rene Gauducheau | |||
| Jean-Yves DOUILLARD, Pr | |||
| Narbonne | |||
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| Clinique Les Genets | |||
| André Mathieu, Dr | |||
| Nevers | |||
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| Centre Hospitalier de Nevers | |||
| Dominique Herman, Dr | |||
| Nice | |||
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| Centre Regional de Lutte Contre le Cancer | |||
| Michel Poudenx, Dr | |||
| Orléans | |||
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| CHR D'Orleans - Hopital de la Source | |||
| Adrien DIXMIER, Dr | |||
| Paris | |||
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| Hopital Saint-Louis | |||
| Damien POUESSEL, Dr | |||
| Hopital Tenon | |||
| Valérie GOUNANT, Dr | |||
| Institut Curie Hopital | |||
| Catherine DANIEL, Dr | |||
| Pau | |||
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| Centre Hospitalier - Pau | |||
| Aldo RENAULT, Dr | |||
| Email: contact@ifct.fr | |||
| Pierre Bénite | |||
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| Centre Hospitalier Lyon Sud | |||
| Pierre-Jean Souquet, Dr | |||
| Poitiers | |||
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| CHU Poitiers | |||
| Corinne LAMOUR, MD | |||
| Pontoise | |||
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| Hopital Rene Dubos | |||
| Gislaine Fraboulet, Dr | |||
| Reims | |||
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| CHU - Robert Debre | |||
| François LEBARGY, Pr | |||
| Rennes | |||
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| Centre Hospitalier Universitaire de Rennes | |||
| Hervé LENA, Dr | |||
| Roubaix | |||
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| Centre Hospitalier de Roubaix | |||
| François STEENHOUWER, Dr | |||
| Rouen | |||
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| Centre Hospitalier Universitaire de Rouen | |||
| Luc Thiberville, Pr | |||
| Saint Brieuc | |||
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| Centre Hospitalier de Saint - Brieuc | |||
| Daniel Coëtmeur, Dr | |||
| Saint Priest en Jarez | |||
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| Institut de Cancerologie de la Loire | |||
| Pierre FOURNEL | |||
| Email: contact@ifct.fr | |||
| Saint Quentin | |||
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| Centre Hospitalier de Saint-Quentin | |||
| Charles Dayen, Dr | |||
| Saint-Malo | |||
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| Centre Hospitalier General De Saint-Malo | |||
| Hugues MOREL, Dr | |||
| Saint-Nazaire | |||
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| Centre Etienne Dolet | |||
| Catherine LIGEZA POISSON | |||
| Centre Hospitalier General de Saint Nazaire | |||
| Daniel SANDRON, Dr | |||
| Strasbourg | |||
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| Hopitaux Universitaire de Strasbourg | |||
| Elisabeth QUOIX, Pr | |||
| Suresnes | |||
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| Hopital Foch | |||
| Sylvie Friard, Dr | |||
| Thonon les bains | |||
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| Center Hospitalier Intercommunal Les Hopitaux du Leman | |||
| Philippe ROMAND, Dr | |||
| Toulon | |||
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| Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer | |||
| Clarisse Audigier-Valette, Dr | |||
| Toulouse | |||
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| CHU de Toulouse, Hotel Dieu | |||
| Julien Mazieres, Pr | |||
| Tours | |||
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| CHU de Tours | |||
| Eric Pichon, Dr | |||
| Valence | |||
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| Centre Hospitalier Valence | |||
| Philippe BRUN | |||
| Email: contact@ifct.fr | |||
| Valenciennes | |||
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| Centre Hospitalier de Valenciennes | |||
| Thomas GEY, Dr | |||
| Vesoul | |||
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| Centre Hospitalier Intercommunal de la Haute-Saone | |||
| Jean-Pierre GURY | |||
| Jean-Pierre GURY | Principal Investigator | ||
| Villefranche | |||
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| Centre Hospitalier de Villefranche sur Saone | |||
| Lionel FALCHERO | |||
| Villejuif | |||
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| Institut Gustave Roussy | |||
| Jacques Margery, Dr | Ph: +33 1 42 11 42 11 | ||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00651456
Information obtained from ClinicalTrials.gov on February 20, 2013
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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