Clinical trial NCT00651456: Mesothelioma Avastin Plus Pemetrexed-cisplatin 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Mesothelioma
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
Collaborators: name: University Hospital, Caen
name: Groupe Francais De Pneumo-Cancerologie
First posted: 2008-04-02
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: % of patients with controled disease (responder and stable patients) at 6 months
timeFrame: 3-month
Secondary outcomes:
measure: Overall Survival
timeFrame: month
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
timeFrame: month
Other outcomes:
measure: Medico-economic assessments of drugs (direct/indirect costs)
timeFrame: 3-month
Locations:
city: Aix-en-Provence
country: France
facility: Centre Hospitalier du Pays d'Aix
city: Ambilly
country: France
facility: Annemasse - CH
city: Amiens
country: France
facility: Amiens - CHU
city: Amiens
country: France
facility: Clinique de l'Europe
city: Angers
country: France
facility: Angers - CHU
city: Auxerre
country: France
facility: Auxerre - CH
city: Besancon
country: France
facility: CHU Besancon - Pneumologie
city: Bobigny
country: France
facility: Bobigny - Hôpital Avicenne
city: Bois-Guillaume
country: France
facility: Bois-Guillaume - CHU
city: Boujan sur Libron
country: France
facility: Boujan sur Libron - Polyclinique Saint-Privat
city: Boulogne
country: France
facility: Hôpital Ambroise Paré - Pneumologie
city: Brest
country: France
facility: Brest - CHU
city: Brest
country: France
facility: Brest - HIA
city: Béziers
country: France
facility: Béziers - CH
city: Caen
country: France
facility: Caen - Centre François Baclesse
city: Caen
country: France
facility: CHU - Pneumologie
city: Chauny
country: France
facility: Chauny - CH
city: Cherbourg
country: France
facility: Cherbourg - CH
city: Clamart
country: France
facility: Hôpital Percy-Armées - Pneumologie
city: Clermont-Ferrand
country: France
facility: CHU
city: Colmar
country: France
facility: Colmar - CH
city: Créteil
country: France
facility: Créteil - CHI
city: Denain
country: France
facility: Denain - CH
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Dijon
country: France
facility: CHU Hôpital du Bocage
city: Elbeuf
country: France
facility: Elbeuf - CH
city: Evreux
country: France
facility: Evreux - CH
city: Flers
country: France
facility: Flers - CH
city: Grenoble
country: France
facility: CHU Grenoble - pneumologie
city: Le Coudray
country: France
facility: Chartres - CH
city: Le Havre
country: France
facility: Centre Hospitalier - Pneumologie
city: Le Havre
country: France
facility: Le Havre - HPE
city: Le Mans
country: France
facility: Centre Hospitalier - Pneumologie
city: Le Mans
country: France
facility: Le Mans - Clinique Victor Hugo
city: Lille
country: France
facility: CHU (Hôpital Calmette) - Pneumologie
city: Limoges
country: France
facility: Limoges - Hôpital du Cluzeau
city: Longjumeau
country: France
facility: CH de Longjumeau
city: Lorient
country: France
facility: Lorient - CHBS
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: HCL - Croix-Rousse
city: Marseille
country: France
facility: APHM - Hôpital Sainte Marguerite
city: Meaux
country: France
facility: Meaux - CH
city: Mont de Marsan
country: France
facility: Mont de Marsan - CH
city: Montpellier
country: France
facility: Montpellier - CHRU
city: Mulhouse
country: France
facility: Mulhouse - CH
city: Nancy
country: France
facility: CHU
city: Nantes
country: France
facility: Nantes - Centre René Gauducheau
city: Narbonne
country: France
facility: Narbonne - Polyclinique Le Languedoc
city: Nevers
country: France
facility: Nevers - CH
city: Nice
country: France
facility: Nice - CAC
city: Orléans
country: France
facility: Orléans - CH
city: Paray Le Monial
country: France
facility: Paray Le Monial - CH
city: Paray Le Monial
country: France
facility: Paray Le Monial - Clinique
city: Paris
country: France
facility: Paris - Saint Louis
city: Paris
country: France
facility: APHP - Hopital Tenon - Pneumologie
city: Paris
country: France
facility: Paris - Curie
city: Pau
country: France
facility: Pau - CH
city: Pierre Bénite
country: France
facility: HCL - Lyon Sud (Pneumologie)
city: Poitiers
country: France
facility: CHU
city: Pontoise
country: France
facility: Pontoise - CH
city: Reims
country: France
facility: Reims - CHU
city: Rennes
country: France
facility: Rennes - CHU
city: Roubaix
country: France
facility: Roubaix - CH
city: Rouen
country: France
facility: Rouen - CHU
city: Saint Brieuc
country: France
facility: Saint Brieuc - CHG
city: Saint Priest en Jarez
country: France
facility: Institut de Cancérologie de la Loire
city: Saint Quentin
country: France
facility: Saint Quentin - CH
city: Saint-Malo
country: France
facility: Saint-Malo - CH
city: Saint-Nazaire
country: France
facility: Centre Etienne Dolet
city: Saint-Nazaire
country: France
facility: Saint-Nazaire - CH
city: Strasbourg
country: France
facility: Strasbourg - NHC
city: Suresnes
country: France
facility: Suresnes - Hopital Foch
city: Thonon les bains
country: France
facility: Thonon les bains - CH
city: Toulon
country: France
facility: Toulon - CHI
city: Toulouse
country: France
facility: CHU Toulouse - Pneumologie
city: Tours
country: France
facility: Tours - CHU
city: Valence
country: France
facility: CH Valence
city: Valenciennes
country: France
facility: Valenciennes - Clinique
city: Vesoul
country: France
facility: CHI de la Haute-Saône - Pneumologie
city: Villefranche
country: France
facility: CH de Villefranche - Pneumologie
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: GFPC
name: Gilles Robinet, Dr
role: STUDY_DIRECTOR
affiliation: Intergroupe Francophone de Cancerologie Thoracique
name: Arnaud Scherpereel, Dr
role: STUDY_DIRECTOR
References:
citation: Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Riviere F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-1414. doi: 10.1016/S0140-6736(15)01238-6. Epub 2015 Dec 21.
citation: Brosseau S, Danel C, Scherpereel A, Mazieres J, Lantuejoul S, Margery J, Greillier L, Audigier-Valette C, Gounant V, Antoine M, Moro-Sibilot D, Rouquette I, Molinier O, Corre R, Monnet I, Langlais A, Morin F, Bergot E, Zalcman G, Levallet G. Shorter Survival in Malignant Pleural Mesothelioma Patients With High PD-L1 Expression Associated With Sarcomatoid or Biphasic Histology Subtype: A Series of 214 Cases From the Bio-MAPS Cohort. Clin Lung Cancer. 2019 Sep;20(5):e564-e575. doi: 10.1016/j.cllc.2019.04.010. Epub 2019 May 13.
citation: Ribi K, Luo W, Colleoni M, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Di Lauro V, Gomez HL, Ruhstaller T, Abdi E, Biganzoli L, Muller B, Barbeaux A, Graas MP, Rabaglio M, Francis PA, Foukakis T, Pagani O, Graiff C, Vorobiof D, Maibach R, Di Leo A, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J; SOLE Investigators. Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. Br J Cancer. 2019 May;120(10):959-967. doi: 10.1038/s41416-019-0435-4. Epub 2019 Apr 10.