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Mesothelioma Avastin Plus Pemetrexed-cisplatin Study (MAPS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00651456
First Posted: April 2, 2008
Last Update Posted: September 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University Hospital, Caen
Groupe Francais De Pneumo-Cancerologie
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: month ]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 [ Time Frame: month ]

Other Outcome Measures:
  • Medico-economic assessments of drugs (direct/indirect costs) [ Time Frame: 3-month ]

Enrollment: 448
Study Start Date: February 2008
Study Completion Date: September 2016
Primary Completion Date: January 2015 (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

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651456


  Show 81 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:
Publications:
Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT00651456     History of Changes
Other Study ID Numbers: IFCT-GFPC-0701
First Submitted: March 29, 2008
First Posted: April 2, 2008
Last Update Posted: September 2, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Cisplatin
Bevacizumab
Pemetrexed
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors