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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)


Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Mesothelioma

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

% of patients with controled disease (responder and stable patients) at 6 months

Outcome Time Frame:

3-month

Safety Issue:

Yes

Principal Investigator

Gilles Robinet, Dr

Investigator Role:

Study Director

Investigator Affiliation:

GFPC

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IFCT-GFPC-0701

NCT ID:

NCT00651456

Start Date:

February 2008

Completion Date:

December 2014

Related Keywords:

  • Mesothelioma
  • Mesothelioma

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