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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Neoadjuvant therapy with 15 mg/kg, IV on Day 1 of each 21 day cycle for the first 2 cycles.
Neoadjuvant therapy, AUC 6, IV on day 1 of each 21 day cycle for 3 cycles.
Neoadjuvant therapy, 75 mg/m2, IV on day 1 of each 21 day cycle for 3 cycles.
Standard surgery after 3 cycles of neoadjuvant therapy with docetaxel, carboplatin, and bevacizumab. Bevacizumab is given for the first 2 cycles only.
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Clinical response rate by CT scan after 3 courses of induction treatment
Time frame: After 3 cycles of induction treatment
Pathologic response rate after 3 courses of induction treatment
Time frame: After 3 cycles of induction treatment
Resectability rate after 3 courses of induction treatment
Time frame: After 3 cycles of induction treatment
Median survival at 2 years after surgery
Time frame: 2 years after surgery
Safety after 3 courses of induction treatment
Time frame: After 3 cycles of induction treatment
Overall survival at 2 years after surgery
Time frame: 2 years after surgery
Time to treatment failure within 2 years after surgery
Time frame: 2 years after surgery
Correlation of serum VEGF levels prior to neoadjuvant therapy with primary and secondary objectives prior to start of induction treatment
Time frame: Before induction treatment
Correlation of serum VEGF expression in resected tumor with primary and secondary objectives
Time frame: After surgical removal of tumor
Correlation of VEGF levels measured immediately after resection and after adjuvant bevacizumab therapy with primary and secondary objectives
Time frame: After resection and after adjuvant bevacizumab
Assay additional downstream VEGF activation pathway markers
Time frame: At any time during the study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.