Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-line Therapy in Patients With Malignant Pleural Mesothelioma
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 treatment failure (TTF);
- the overall survival (OS)
- RR, TTP and OS according to baseline plasma VEGF levels (introduced with Amendment 1
dated 8/11/2007)
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression (TTP) from first day of treatment until first observation of disease progression or death due to any cause or the last date the patient was known to be progression free or alive.
At the end of study
No
Armando Santoro, MD
Principal Investigator
Istituto Clinico Humanitas
Italy: Ministry of Health
ONC-2006-003
NCT00407459
September 2007
November 2010
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