Docetaxel, Carboplatin, and Bevacizumab in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed By Surgery
- Conditions
- Lung Cancer
- Registration Number
- NCT00293332
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Clinical response rate by CT scan after 3 courses of induction treatment After 3 cycles of induction treatment
- Secondary Outcome Measures
Name Time Method Pathologic response rate after 3 courses of induction treatment After 3 cycles of induction treatment Resectability rate after 3 courses of induction treatment After 3 cycles of induction treatment Median survival at 2 years after surgery 2 years after surgery Safety after 3 courses of induction treatment After 3 cycles of induction treatment Overall survival at 2 years after surgery 2 years after surgery Time to treatment failure within 2 years after surgery 2 years after surgery Correlation of serum VEGF levels prior to neoadjuvant therapy with primary and secondary objectives prior to start of induction treatment Before induction treatment Correlation of serum VEGF expression in resected tumor with primary and secondary objectives After surgical removal of tumor Correlation of VEGF levels measured immediately after resection and after adjuvant bevacizumab therapy with primary and secondary objectives After resection and after adjuvant bevacizumab Assay additional downstream VEGF activation pathway markers At any time during the study
Trial Locations
- Locations (1)
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States