NCT00251524

A Phase II Study of Eloxatin and Alimta in Combination With Bevacizumab in Advanced Non-Squamous NSCLC

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Veeda Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, open-label, non-randomized study in patients with advanced non-squamous NSCLC. Each cycle will be 21 days. Patients will be evaluated every 2 cycles (\~6 weeks) for response using RECIST criteria. Those patients achieving stable disease or better will continue therapy. Those patients experiencing progressive disease will be taken off study. Patients will receive 6 cycles of Eloxatin, Alimta, and Bevacizumab. After the 6 cycles, patients will receive Bevacizumab alone every 21 days until evidence of disease progression or unacceptable toxicity. Note: Once patient has completed the 6 cycles of Eloxatin, Alimta, and Bevacizumab and is receiving single-agent Bevacizumab, assessment of response will be performed every 3 cycles (\~every 9 weeks) using RECIST criteria.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab, Oxaliplatin, Pemetrexed	Avastin 15 mg/kg IV, Alimta 500 mg/m2 IV given over 10 minutes, Eloxatin 120 mg/m2 IV given over 2 hours

Timeline

• Start date: 2005-11-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2005-11-10
• Last updated: 2012-05-11

Locations

1 site across 1 country: United States