A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
% of patients with controled disease (responder and stable patients) at 6 months
3-month
Yes
Gilles Robinet, Dr
Study Director
GFPC
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
IFCT-GFPC-0701
NCT00651456
February 2008
December 2014
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