A Phase 2/3 interventional study of Standard Chemotherapy (Pemetrexed and Cisplatin) and Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab in Mesothelioma, sponsored by Intergroupe Francophone de Cancerologie Thoracique. Completed at 81 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-13.
Sponsored by Intergroupe Francophone de Cancerologie Thoracique · Phase 2/3, Interventional, and Treatment
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.
470 studies on the registry are indexed under Mesothelioma; 75 are open to participants now.
This study's enrollment of 448 is above the median of 40 across 371 interventional studies indexed under Mesothelioma.
Browse Mesothelioma studies →Intergroupe Francophone de Cancerologie Thoracique is the lead sponsor of 57 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard Chemotherapy
Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)
Standard Chemotherapy + bevacizumab (Avastin)
Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
* 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
Medico-economic assessments of drugs (direct/indirect costs)
Time frame: 3-month
Plan to share: Undecided
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Intergroupe Francophone de Cancerologie Thoracique