A Safety and Feasibility Study of Bevacizumab With Paclitaxel, Carboplatin and Chest Radiotherapy in Patients With Locally Advanced Non-Small Lung Cancer
I. Assess the feasibility of administering bevacizumab, paclitaxel, carboplatin, and chest
radiotherapy in patients with locally advanced non-small cell lung cancer.
II. Characterize the toxicity of this treatment regimen. III. Assess the clinical response
to this treatment regimen. IV. Correlate circulating levels of angiopoietin-2 and vascular
endothelial growth factor receptor-2 with clinical response to this treatment regimen.
OUTLINE: This is an open-label, multicenter study.Induction therapy.
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30-60 minutes on days 1,
8, 15, 22, 29, 36, and 43 and bevacizumab IV over 30-90 minutes on days 1, 15, 29, and 43.
Patients also undergo chest radiotherapy 5 days a week for 7 weeks beginning on day 1.
Consolidation therapy: Beginning 4-5 weeks after completion chemoradiotherapy, patients
receive paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour followed by
bevacizumab IV over 30 minutes. Treatment repeats every 21 days for 3 courses in the absence
of disease progression or unacceptable toxicity.
After study completion, patients are followed periodically for 36 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and feasibility
Up to 36 months
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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