Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma
Phase 2
Completed
- Conditions
- Mesothelioma
- Registration Number
- NCT00407459
- Lead Sponsor
- Armando Santoro, MD
- 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 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
Inclusion Criteria
- 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 Criteria
- Uncontrolled hypertension
- Evidence of bleeding diathesis or coagulopathy
- Pregnancy or breast-feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Response rate (RR) assessed according to modified RECIST criteria for Malignant Pleural Mesothelioma. Two months after the end of enrollment Overall survival (OS) computed as the time between the first day of treatment and the date of death or the last date the patient was known to be alive. At the end of study
Trial Locations
- Locations (1)
Istituto Clinico Humanitas
🇮🇹Rozzano, Milan, Italy