Mesothelioma Avastin Plus Pemetrexed-cisplatin Study
- Conditions
- Mesothelioma
- Interventions
- Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
- Registration Number
- NCT00651456
- Lead Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 448
- 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
- Prior chemotherapy
- Brain metastasis
- History of cerebral vascular accident (CVA) or transient ischemic attack
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Standard Chemotherapy (Pemetrexed and Cisplatin) Standard Chemotherapy 2 Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab Standard Chemotherapy + bevacizumab (Avastin)
- Primary Outcome Measures
Name Time Method % of patients with controled disease (responder and stable patients) at 6 months 3-month
- Secondary Outcome Measures
Name Time Method Overall Survival month Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 month
Trial Locations
- Locations (78)
Caen - Centre François Baclesse
🇫🇷Caen, France
CHU
🇫🇷Poitiers, France
APHM - Hôpital Sainte Marguerite
🇫🇷Marseille, France
Meaux - CH
🇫🇷Meaux, France
Nantes - Centre René Gauducheau
🇫🇷Nantes, France
Mont de Marsan - CH
🇫🇷Mont de Marsan, France
Narbonne - Polyclinique Le Languedoc
🇫🇷Narbonne, France
Nevers - CH
🇫🇷Nevers, France
Nice - CAC
🇫🇷Nice, France
Orléans - CH
🇫🇷Orléans, France
Pau - CH
🇫🇷Pau, France
Reims - CHU
🇫🇷Reims, France
Saint-Malo - CH
🇫🇷Saint-Malo, France
Bobigny - Hôpital Avicenne
🇫🇷Bobigny, France
CHU Besancon - Pneumologie
🇫🇷Besancon, France
Angers - CHU
🇫🇷Angers, France
Amiens - CHU
🇫🇷Amiens, France
Annemasse - CH
🇫🇷Ambilly, France
Clinique de l'Europe
🇫🇷Amiens, France
Bois-Guillaume - CHU
🇫🇷Bois-Guillaume, France
Brest - CHU
🇫🇷Brest, France
Montpellier - CHRU
🇫🇷Montpellier, France
Denain - CH
🇫🇷Denain, France
CHU - Pneumologie
🇫🇷Caen, France
Chauny - CH
🇫🇷Chauny, France
HCL - Croix-Rousse
🇫🇷Lyon, France
Colmar - CH
🇫🇷Colmar, France
Paray Le Monial - CH
🇫🇷Paray Le Monial, France
Mulhouse - CH
🇫🇷Mulhouse, France
Rouen - CHU
🇫🇷Rouen, France
Saint Brieuc - CHG
🇫🇷Saint Brieuc, France
Centre Hospitalier du Pays d'Aix
🇫🇷Aix-en-Provence, France
Auxerre - CH
🇫🇷Auxerre, France
Boujan sur Libron - Polyclinique Saint-Privat
🇫🇷Boujan sur Libron, France
Hôpital Ambroise Paré - Pneumologie
🇫🇷Boulogne, France
Béziers - CH
🇫🇷Béziers, France
Brest - HIA
🇫🇷Brest, France
Cherbourg - CH
🇫🇷Cherbourg, France
Hôpital Percy-Armées - Pneumologie
🇫🇷Clamart, France
Centre Georges François Leclerc
🇫🇷Dijon, France
Créteil - CHI
🇫🇷Créteil, France
CHU Hôpital du Bocage
🇫🇷Dijon, France
Elbeuf - CH
🇫🇷Elbeuf, France
Evreux - CH
🇫🇷Evreux, France
Flers - CH
🇫🇷Flers, France
CHU Grenoble - pneumologie
🇫🇷Grenoble, France
Chartres - CH
🇫🇷Le Coudray, France
Centre Hospitalier - Pneumologie
🇫🇷Le Mans, France
Limoges - Hôpital du Cluzeau
🇫🇷Limoges, France
CHU (Hôpital Calmette) - Pneumologie
🇫🇷Lille, France
Le Mans - Clinique Victor Hugo
🇫🇷Le Mans, France
Le Havre - HPE
🇫🇷Le Havre, France
CH de Longjumeau
🇫🇷Longjumeau, France
Centre Léon Bérard
🇫🇷Lyon, France
Lorient - CHBS
🇫🇷Lorient, France
Paris - Saint Louis
🇫🇷Paris, France
APHP - Hopital Tenon - Pneumologie
🇫🇷Paris, France
Paray Le Monial - Clinique
🇫🇷Paray Le Monial, France
Paris - Curie
🇫🇷Paris, France
HCL - Lyon Sud (Pneumologie)
🇫🇷Pierre Bénite, France
Roubaix - CH
🇫🇷Roubaix, France
Pontoise - CH
🇫🇷Pontoise, France
Rennes - CHU
🇫🇷Rennes, France
Institut de Cancérologie de la Loire
🇫🇷Saint Priest en Jarez, France
Saint Quentin - CH
🇫🇷Saint Quentin, France
Centre Etienne Dolet
🇫🇷Saint-Nazaire, France
Saint-Nazaire - CH
🇫🇷Saint-Nazaire, France
Strasbourg - NHC
🇫🇷Strasbourg, France
Suresnes - Hopital Foch
🇫🇷Suresnes, France
Toulon - CHI
🇫🇷Toulon, France
Thonon les bains - CH
🇫🇷Thonon les bains, France
CHU Toulouse - Pneumologie
🇫🇷Toulouse, France
Tours - CHU
🇫🇷Tours, France
Valenciennes - Clinique
🇫🇷Valenciennes, France
CH Valence
🇫🇷Valence, France
CHI de la Haute-Saône - Pneumologie
🇫🇷Vesoul, France
CH de Villefranche - Pneumologie
🇫🇷Villefranche, France
Institut Gustave Roussy
🇫🇷Villejuif, France