Mesothelioma Avastin Plus Pemetrexed-cisplatin Study - Full Text View

Sponsor:	Intergroupe Francophone de Cancerologie Thoracique
Collaborators:	University Hospital, Caen Groupe Francais De Pneumo-Cancerologie
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)

Resource links provided by NLM:

MedlinePlus related topics: Mesothelioma

Drug Information available for: Cisplatin Pemetrexed Pemetrexed disodium Bevacizumab

U.S. FDA Resources

Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:

Primary Outcome Measures:

% of patients with controled disease (responder and stable patients) at 6 months [ Time Frame: 3-month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall Survival [ Time Frame: month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	445
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Standard Chemotherapy	Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation Day 1 (D1=D22, 6 cycles) Cisplatin 75 mg/m² Day 1 (D1=D22, 6 cycles)
Experimental: 2 Standard Chemotherapy + bevacizumab (Avastin)	Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation D1 (D1=D22, 6 cycles) Cisplatin 75 mg/m2 D1 (D1=D22, 6 cycles) Bevacizumab 15 mg/kg D1 (D1=D22, until progression)

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651456

Contacts

Contact: Gérard Zalcman, Pr	33-2-31-06-44-76
Contact: Franck Morin		contact@ifct.fr

Locations

Belgium
Institut Jules Bordet	Recruiting
Bruxelles, Belgium, 1000
Contact: Thierry Berghmans, Dr +32 25 41 31 11
France
Centre Hospitalier - Pneumologie	Recruiting
Belfort, France, 90016
Contact: Jean-Luc Breton, Dr +33 3 84 98 51 18
CHU Besancon - Pneumologie	Recruiting
Besancon, France, 25000
Contact: Pascale Jacoulet, Dr
CHU - Pneumologie	Recruiting
Caen, France, 14000
Contact: Gerard Zalcman, Pr
Hôpital Percy-Armées - Pneumologie	Recruiting
Clamart, France, 92140
Contact: Jacques Margery, Dr
CHU Grenoble - pneumologie	Recruiting
Grenoble, France, 38000
Contact: Denis Moro-Sibilot, Pr
Principal Investigator: Denis Moro-Sibilot, Pr
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
CHU (Hôpital Calmette) - Pneumologie	Recruiting
Lille, France, 59000
Contact: Arnaud Scherpereel, Dr
HCL - Croix-Rousse	Recruiting
Lyon, France, 69000
Contact: Maurice Pérol, Dr
APHM - Hôpital Sainte Marguerite	Recruiting
Marseille, France, 13000
Contact: Philippe ASTOUL, Pr
APHP - Hopital Tenon - Pneumologie	Recruiting
Paris, France, 75020
Contact: Bernard MILLERON, Dr
HCL - Lyon Sud (Pneumologie)	Recruiting
Pierre Bénite, France, 69495
Contact: Pierre-Jean Souquet, Dr
CHU Lyautey - Pneumologie	Recruiting
Strasbourg, France, 63000
Contact: Elisabeth Quoix, Pr
Principal Investigator: Elisabeth Quoix, Pr
CHU Toulouse - Pneumologie	Recruiting
Toulouse, France
Contact: Julien Mazieres, Pr
Institut Gustave Roussy	Recruiting
Villejuif, France, 94805
Contact: Pierre Ruffié, Dr +33 1 42 11 42 11

Sponsors and Collaborators

Intergroupe Francophone de Cancerologie Thoracique

University Hospital, Caen

Groupe Francais De Pneumo-Cancerologie

Investigators

Study Director:	Gilles Robinet, Dr	GFPC
Study Director:	Arnaud Scherpereel, Dr	IFCT

More Information

Additional Information:

Official website This link exits the ClinicalTrials.gov site

Publications:

Porret E, Madelaine J, Galateau-Sallé F, Bergot E, Zalcman G. [Epidemiology, molecular biology, diagnostic and therapeutic strategy of malignant pleural mesothelioma in 2007 - an update] Rev Mal Respir. 2007 Oct;24(8 Pt 2):6S157-64. French.

Responsible Party:	Pr Gérad Zalcman, IFCT
ClinicalTrials.gov Identifier:	NCT00651456 History of Changes
Other Study ID Numbers:	IFCT-GFPC-0701
Study First Received:	March 29, 2008
Last Updated:	September 5, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Pemetrexed
Bevacizumab
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

Radiation-Sensitizing Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012