NCT00755170

Metronomic Vinorelbine and Bevacizumab in Patients With Non Small Cell Lung Cancer

A Phase II Study of the Combination of Metronomic Vinorelbine and Bevacizumab as 2nd Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will evaluate the efficacy and safety of metronomic vinorelbine and bevacizumab combination in patients with pretreated, advanced non small cell lung cancer

Detailed description

Intravenous (IV) vinorelbine is a standard chemotherapy option for the treatment of metastatic NSCLC, either alone or in combination with other agents such as CDDP or Carboplatin with overall response rates (ORR) of 15-35% as 1st line treatment and less than 10% as salvage treatment. For the past few years vinorelbine is available for per os (po) administration with acceptable and reliable pharmacokinetic profiles and with a bioavailability of approximately 40% of the IV dose. In randomized phase II studies IV and po vinorelbine have shown comparable response and overall survival rates. The low dose metronomic chemotherapy that is administered in short intervals has been shown in vitro an in vivo to have antiangiogenic effects. Bevacizumab is a well known anti-angiogenic agent. Recently, a phase III study of 1st line treatment in patients with advanced or metastatic NSCLC showed that the addition of bevacizumab to a platinum-based regimen provided a survival benefit. This study will evaluate the combination of metronomic vinorelbine and bevavizumab as 2nd line treatment of NSCLC.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Vinorelbine	Metronomic vinorelbine (p.o) 30 mg total dose/day, every Monday, Wednesday and Friday of each week, continuously without intervals for the equivalence of 6 cycles maximum
DRUG	Bevacizumab	Bevacizumab (IV) 10 mgr/Kgr on day 1 and 15 every 4 weeks for 6 cycles maximum followed by Bevacizumab (IV) 10 mgr/Kgr on day 1 and 15 every 4 weeks until disease progression

Timeline

• Start date: 2008-11-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2008-09-18
• Last updated: 2016-10-04

Locations

9 sites across 1 country: Greece