Status:
COMPLETED
Mesothelioma Avastin Plus Pemetrexed-cisplatin Study
Lead Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Collaborating Sponsors:
University Hospital, Caen
Groupe Francais De Pneumo-Cancerologie
Conditions:
Mesothelioma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
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.
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...
Eligibility Criteria
Inclusion
- 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
- Prior chemotherapy
- Brain metastasis
- History of cerebral vascular accident (CVA) or transient ischemic attack
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
448 Patients enrolled
Trial Details
Trial ID
NCT00651456
Start Date
February 1 2008
End Date
September 1 2016
Last Update
March 13 2023
Active Locations (81)
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1
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France
2
Annemasse - CH
Ambilly, France, 74100
3
Amiens - CHU
Amiens, France
4
Clinique de l'Europe
Amiens, France