Mesothelioma Avastin Plus Pemetrexed-cisplatin Study (MAPS)
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ClinicalTrials.gov Identifier: NCT00651456 |
Recruitment Status :
Completed
First Posted : April 2, 2008
Last Update Posted : September 2, 2016
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Condition or disease | Intervention/treatment | Phase |
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Mesothelioma | Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 448 participants |
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) |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | September 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Standard Chemotherapy
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Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)
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Experimental: 2
Standard Chemotherapy + bevacizumab (Avastin)
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Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
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- % of patients with controled disease (responder and stable patients) at 6 months [ Time Frame: 3-month ]
- Overall Survival [ Time Frame: month ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 [ Time Frame: month ]
- Medico-economic assessments of drugs (direct/indirect costs) [ Time Frame: 3-month ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Study Director: | Gilles Robinet, Dr | GFPC | |
Study Director: | Arnaud Scherpereel, Dr | Intergroupe Francophone de Cancerologie Thoracique |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Intergroupe Francophone de Cancerologie Thoracique |
ClinicalTrials.gov Identifier: | NCT00651456 |
Other Study ID Numbers: |
IFCT-GFPC-0701 |
First Posted: | April 2, 2008 Key Record Dates |
Last Update Posted: | September 2, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Mesothelioma Mesothelioma, Malignant Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Pleural Neoplasms Lung Diseases Respiratory Tract Diseases |
Bevacizumab Cisplatin Pemetrexed Antineoplastic Agents, Immunological 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 |