Vinorelbine and Bevacizumab in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving vinorelbine together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vinorelbine together with bevacizumab works in treating older patients with stage III or stage IV non-small cell lung cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vinorelbine Plus Bevacizumab as First Line Therapy in Patients ≥ 70 Years of Age With Stage IIIB/IV Non-Squamous, Non-Small Cell Lung Cancer|
- Median time to disease progression by imaging study every 6 weeks [ Designated as safety issue: No ]
- Response rate by imaging study every 6 weeks [ Designated as safety issue: No ]
- Median survival [ Designated as safety issue: No ]
- Safety as measured by toxicity (e.g thromboembolism, bleeding, or bowel perforation) every three weeks or as required [ Designated as safety issue: Yes ]
|Study Start Date:||September 2005|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309998
|United States, New York|
|James P. Wilmot Cancer Center at University of Rochester Medical Center|
|Rochester, New York, United States, 14642-0001|
|Study Chair:||Deepak M. Sahasrabudhe, MD||James P. Wilmot Cancer Center|