Bevacizumab and Docetaxel in Treating Older Patients With Stage III-IV Non-Small Cell Lung Cancer
This phase II trial studies how well giving bevacizumab together with docetaxel works in treating older patients with stage III-IV non-small cell lung cancer. 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. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel may kill more tumor cells
Adenocarcinoma of the Lung
Bronchoalveolar Cell Lung Cancer
Large Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Avastin and Weekly Docetaxel in Elderly (>= 75 Years) Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)|
- Objective response [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]Descriptive statistics (point and exact 90% confidence interval estimates) will be generated.
- Progression-free survival (PFS) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
- Overall survival (OS) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: Every 2-4 courses and at 4 weeks after completion of treatment ] [ Designated as safety issue: No ]
- Toxicity rate [ Time Frame: At days 1 and 15 of each course for the first 4 courses, and then once every course ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (monoclonal antibody and chemotherapy)
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: docetaxel
I. To determine the proportion of elderly (>= 75 years) patients with advanced non-small cell lung cancer (NSCLC) surviving for at least 6 months when treated with combination of Avastin (bevacizumab) and weekly docetaxel.
I. To assess the progression free survival and overall survival. II. To determine the response rate with this regimen. III. To assess the toxicity of this regimen.
Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15 and docetaxel IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks and then up to 6 months.
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Shirish Gadgeel||Barbara Ann Karmanos Cancer Institute|