drugset / Trial / NCT00251524

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

NCT00251524 ↗

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2005-11
Primary completion
2009-05
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Oxaliplatin Small molecule 120 mg/m2 Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous