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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Start Date
December 1, 2005
Primary Completion Date
March 1, 2007
Completion Date
April 1, 2007
Last Updated
February 9, 2011
1
ACTUAL participants
bevacizumab
BIOLOGICAL
carboplatin
DRUG
docetaxel
DRUG
conventional surgery
PROCEDURE
Lead Sponsor
University of California, San Francisco
Collaborators
NCT07486219
NCT06498635
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07190248