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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
448
* 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)
* 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)
% 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
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...and 71 more locations