Lung Cancer Clinical Trial
Official title:
A Phase II Study of Neoadjuvant Therapy With Docetaxel, Carboplatin, and Bevacizumab in Patients With Resectable Early Stage Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, 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 docetaxel and carboplatin
together with bevacizumab before surgery may make the tumor smaller and reduce the amount of
normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together
with bevacizumab works in treating patients with stage I, stage II, or stage III non-small
cell lung cancer that can be removed by surgery.
OBJECTIVES:
Primary
- Determine the clinical response rate in patients with stage IB-IIIA non-small cell lung
cancer treated with neoadjuvant docetaxel, carboplatin, and bevacizumab.
Secondary
- 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
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