Mesothelioma Avastin Plus Pemetrexed-cisplatin Study - Full Text View

Sponsors and Collaborators:	Intergroupe Francophone de Cancerologie Thoracique CHU de Caen Groupe Francais de Pneumo-Cancérologie European Lung Cancer Working Party
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:	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)

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:	November 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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)
2: Experimental 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		franck.morin@ifct.fr

Locations

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

Sponsors and Collaborators

Intergroupe Francophone de Cancerologie Thoracique

CHU de Caen

Groupe Francais de Pneumo-Cancérologie

European Lung Cancer Working Party

Investigators

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

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:	IFCT ( Pr Gérad Zalcman )
Study ID Numbers:	IFCT-GFPC-ELCWP-0701
Study First Received:	March 29, 2008
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00651456 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Antimetabolites
Vitamin B Complex
Cyanocobalamin
Hydroxocobalamin
Folate
Vitamin B 12
Cobalamin
Bevacizumab
Folinic Acid
Folic Acid Antagonists
Angiogenesis Inhibitors

Vitamin B9
Folic Acid
Pemetrexed
Methylcobalamin
Vitamin B12
Cisplatin
Radiation-Sensitizing Agents
Vitamins
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 11, 2009