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Vinorelbine Plus Bevacizumab as First Line Therapy in Patients ≥ 70 Years of Age With Stage IIIB/IV Non-Squamous, 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.
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.
Age
70 - 120 years
Sex
ALL
Healthy Volunteers
No
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Start Date
September 1, 2005
Primary Completion Date
May 1, 2007
Last Updated
October 29, 2024
50
ESTIMATED participants
bevacizumab
BIOLOGICAL
vinorelbine tartrate
DRUG
Lead Sponsor
University of Rochester
NCT06498635
NCT05198830
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