Mesothelioma Avastin Plus Pemetrexed-cisplatin Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)

Conditions
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Mesothelioma

Intervention / Treatment
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* Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)
* Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Standard Chemotherapy | Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)<br>* 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)<br>|
| Experimental: 2<br>Standard Chemotherapy + bevacizumab (Avastin) | Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients with controled disease (responder and stable patients) at 6 months |  | 3-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | month | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 |  | month |