Vinorelbine Plus Bevacizumab as First Line Therapy in Patients ≥ 70 Years of Age With Stage IIIB/IV Non-Squamous, Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- Estimate the median time to disease progression in older patients with non-squamous
stage IIIB or stage IV non-small cell lung cancer (NSCLC) treated with vinorelbine
ditartate and bevacizumab.
Secondary
- Estimate the response rate in patients treated with this regimen.
- Estimate the median survival in patients treated with this regimen.
- Evaluate the safety of the combination of vinorelbine ditartate and bevacizumab in
older patients.
OUTLINE: This is an open-label study.
Patients receive vinorelbine ditartate IV over 6 to 10 minutes on days 1 and 8 and
bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence
of unacceptable toxicity or disease progression.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Median time to disease progression by imaging study every 6 weeks
No
Deepak M. Sahasrabudhe, MD
Study Chair
James P. Wilmot Cancer Center
United States: Food and Drug Administration
CDR0000465498
NCT00309998
September 2005
Name | Location |
---|---|
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |