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Mesothelioma Avastin Plus Pemetrexed-cisplatin Study (MAPS)

This study is currently recruiting participants.
Verified February 2013 by Intergroupe Francophone de Cancerologie Thoracique
Sponsor:
Collaborators:
University Hospital, Caen
Groupe Francais De Pneumo-Cancerologie
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT00651456
First received: March 29, 2008
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
  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 2
Phase 3

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
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

  Show 79 Study Locations
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:

Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT00651456     History of Changes
Other Study ID Numbers: IFCT-GFPC-0701
Study First Received: March 29, 2008
Last Updated: February 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 May 23, 2013