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Mesothelioma Avastin Plus Pemetrexed-Cisplatin Study (MAPS)

This study is currently recruiting participants.
Verified by Intergroupe Francophone de Cancerologie Thoracique, April 2008

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

MedlinePlus related topics:   Mesothelioma   

Drug Information available for:   Cisplatin    Pemetrexed disodium    Pemetrexed    Folic acid    Vitamin B 12    Hydroxocobalamin    Bevacizumab   

U.S. FDA Resources

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)

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


Official website  This link exits the ClinicalTrials.gov site
 

Publications:

Responsible Party:   IFCT ( Pr Gérad Zalcman )
Study ID Numbers:   IFCT-GFPC-ELCWP-0701
First Received:   March 29, 2008
Last Updated:   April 2, 2008
ClinicalTrials.gov Identifier:   NCT00651456
Health Authority:   France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:
Pemetrexed
Folic Acid
Cisplatin
Hydroxocobalamin
Vitamin B 12
Mesothelioma
Bevacizumab
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on November 19, 2008




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