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Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma

Brief Summary

The primary objective is to assess antitumor activity of the combination of bevacizumab, pemetrexed and carboplatin, in terms of time to progression.

Tracking Information
First Received DateDecember 4, 2006
Last Changed DateAugust 31, 2011
Start DateSeptember 2007
Actual Primary Completion DateNovember 2010
Primary Outcome Measures

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. [Time Frame: At the end of study]

Secondary Outcome Measures

Response rate (RR) assessed according to modified RECIST criteria for Malignant Pleural Mesothelioma. [Time Frame: 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. [Time Frame: At the end of study]

Descriptive Information
PhasePhase 2
Study TypeInterventional
  • Mesothelioma
  • Drug: Bevacizumab, Pemetrexed, Carboplatin
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 Information
Recruitment StatusCompleted
Actual Enrollment77
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria

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

Administrative Information
Responsible PartySponsor-Investigator
SponsorArmando Santoro, MD
Verification DateAugust 2011
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