Status:
COMPLETED
Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma
Lead Sponsor:
Armando Santoro, MD
Conditions:
Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective is to assess antitumor activity of the combination of bevacizumab, pemetrexed and carboplatin, in terms of time to progression.
Detailed Description
Secondary endpoints are to evaluate: * the objective response rate (RR) of the combination; * the toxicity and the safety profile of the combination; * the duration of response (RD) and time to treat...
Eligibility Criteria
Inclusion
- Histologically proven malignant pleural mesothelioma, inoperable, non previously treated with chemotherapy including intracavitary administration
- PS 0-1
- Measurable and/or evaluable lesions according to RECIST criteria
- Adequate organ function
Exclusion
- Uncontrolled hypertension
- Evidence of bleeding diathesis or coagulopathy
- Pregnancy or breast-feeding
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00407459
Start Date
September 1 2007
End Date
November 1 2010
Last Update
September 2 2011
Active Locations (1)
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1
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089