A Phase II Study of Neoadjuvant Therapy With Docetaxel, Carboplatin, and Bevacizumab in Patients With Resectable Early Stage Non-Small Cell Lung Cancer
- Determine the clinical response rate in patients with stage IB-IIIA non-small cell lung
cancer treated with neoadjuvant docetaxel, carboplatin, and bevacizumab.
- Determine the median and overall survival of patients treated with this regimen.
- Determine the safety profile of this regimen.
- Determine the time to treatment failure of patients treated with this regimen.
- Determine the pathologic response rate and the resectability rate in patients treated
with this regimen.
- Correlate vascular endothelial growth factor (VEGF) levels or expression with response
and survival of patients treated with this regimen.
OUTLINE: Patients receive docetaxel IV over 15-60 minutes, carboplatin IV over 30-60
minutes, and bevacizumab* IV over 30-90 minutes on day 1. Treatment repeats every 21 days
for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Approximately 4-6 weeks after completion of chemotherapy, eligible patients with no distant
or mediastinal disease progression undergo lobectomy, pneumonectomy, or segmentectomy with
standard radical mediastinal lymph node dissection.
NOTE: *Bevacizumab is only administered during courses 1 and 2.
After completion of study treatment, patients are followed periodically for 8 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical response rate by CT scan after 3 courses of induction treatment
After 3 cycles of induction treatment
Sarita Dubey, MD
University of California, San Francisco
United States: Food and Drug Administration
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|