A Phase II Study of Eloxatin and Alimta in Combination With Bevacizumab in Advanced Non-Squamous NSCLC
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Oxaliplatin | Small molecule | 120 mg/m2 | Intravenous |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |