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Mesothelioma Avastin Plus Pemetrexed-cisplatin Study

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.

Tracking Information
First Received DateMarch 29, 2008
Last Changed DateSeptember 1, 2016
Start DateFebruary 2008
Actual Primary Completion DateJanuary 2015
Primary Outcome Measures

% of patients with controled disease (responder and stable patients) at 6 months [Time Frame: 3-month]

Secondary Outcome Measures

Overall Survival [Time Frame: month]

Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 [Time Frame: month]

Descriptive Information
PhasePhase 2/Phase 3
Study TypeInterventional
Condition
  • Mesothelioma
Intervention
  • Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)
  • Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
Study Arms / Comparison Groups2 / 0
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 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.

Recruitment Information
Recruitment StatusCompleted
Actual Enrollment448
GenderAll
Ages18 Years - 75 Years
Accepts Healthy VolunteersNo
Eligibility Criteria

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

Administrative Information
NCTIDNCT00651456
Responsible Party,
SponsorIntergroupe Francophone de Cancerologie Thoracique
Verification DateSeptember 2016
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