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

Armando Santoro, MD

Status and phase: Completed; Phase 2

Conditions: Mesothelioma

Treatments: Drug: Bevacizumab, Pemetrexed, Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00407459

ONC-2006-003

EUDRACT 2006-004429-27

Details and patient eligibility

About

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

Full 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)

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)