Bevacizumab and Docetaxel in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
- Registration Number
- NCT00541099
- Lead Sponsor
- Barbara Ann Karmanos Cancer Institute
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Avastin & Docetaxel bevacizumab 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 & Docetaxel 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
- Primary Outcome Measures
Name Time Method Survival 6 months when treated with combination of Avastin and weekly docetaxel
- Secondary Outcome Measures
Name Time Method Progression-free Survival 6 months when treated with combination of Avastin and weekly docetaxel Progression-free survival in months via the Kaplan-Meier method
Overall Survival 4 weeks after removal from study or until death Overall survival using Kaplan-Meier method.
Toxicity According to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 1st and 2nd week of each 21 day cycle, up to six cycles. Toxicity: using the highest grade of each toxicity experienced by each patient according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Response Rate Every 8 weeks
Trial Locations
- Locations (3)
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Nevada Cancer Institute
🇺🇸Las Vegas, Nevada, United States