Bevacizumab and Docetaxel in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
RATIONALE: 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, also work in different ways to kill tumor cells or stop them from growing. Giving bevacizumab together with docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel works in treating older patients with stage III or stage IV non-small cell lung cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Bevacizumab and Weekly Docetaxel in Elderly (≥ 75 Years) Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)|
- Survival [ Time Frame: 6 months when treated with combination of Avastin and weekly docetaxel ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 6 months when treated with combination of Avastin and weekly docetaxel ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 4 weeks after removal from study or until death ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 1st and 2nd week of each 21 day cycle ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: Avastin & Docetaxel
Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
Avastin 10.0 mg/kg on days 1 and 15
Other Name: AvastinDrug: docetaxel
Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
Other Name: TAXOTERE®
- To determine the proportion of elderly (≥ 75 years of age) patients with stage III or IV non-small cell lung cancer surviving for at least 6 months when treated with a combination of bevacizumab and weekly docetaxel.
- To assess the progression-free and overall survival of patients treated with this regimen.
- To determine the response rate in patients treated with this regimen.
- To assess the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV on days 1, 8, and 15. Treatment may repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|United States, Nevada|
|Nevada Cancer Institute|
|Las Vegas, Nevada, United States, 89135|
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Shirish M. Gadgeel, MD||Barbara Ann Karmanos Cancer Institute|