NCT00407459

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Armando Santoro, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Mesothelioma

Interventions

Type	Name	Description
DRUG	Bevacizumab, Pemetrexed, Carboplatin	* Bevacizumab: 15 mg/kg intravenous infusion over 30 to 90 minutes, following chemotherapy, on Day 1 every 3 weeks * Pemetrexed: 500 mg/m2 intravenous infusion over 10 minutes on Day 1 every 3 weeks * Carboplatin: AUC 5 intravenous infusion over 1 hour on Day 1 every 3 weeks

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2006-12-05
• Last updated: 2011-09-02

Locations

1 site across 1 country: Italy