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

Phase II Study of the Combination of Bevacizumab Plus Pemetrexed and Carboplatin as First-line Therapy in Patients With Malignant Pleural Mesothelioma

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

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)

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