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
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|ClinicalTrials.gov Identifier: NCT00293332|
Recruitment Status : Terminated (Terminated due to low subject accrual)
First Posted : February 17, 2006
Last Update Posted : February 9, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: bevacizumab Drug: carboplatin Drug: docetaxel Procedure: conventional surgery||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||April 2007|
- Biological: bevacizumab
Neoadjuvant therapy with 15 mg/kg, IV on Day 1 of each 21 day cycle for the first 2 cycles.Other Name: Avastin
- Drug: carboplatin
Neoadjuvant therapy, AUC 6, IV on day 1 of each 21 day cycle for 3 cycles.Other Name: Paraplatin
- Drug: docetaxel
Neoadjuvant therapy, 75 mg/m2, IV on day 1 of each 21 day cycle for 3 cycles.Other Name: Taxotere
- Procedure: conventional surgery
Standard surgery after 3 cycles of neoadjuvant therapy with docetaxel, carboplatin, and bevacizumab. Bevacizumab is given for the first 2 cycles only.Other Name: Resection
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293332
|United States, California|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Study Chair:||Sarita Dubey, MD||University of California, San Francisco|