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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
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
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Survival
Time frame: 6 months when treated with combination of Avastin and weekly docetaxel
Progression-free Survival
Progression-free survival in months via the Kaplan-Meier method
Time frame: 6 months when treated with combination of Avastin and weekly docetaxel
Overall Survival
Overall survival using Kaplan-Meier method.
Time frame: 4 weeks after removal from study or until death
Response Rate
Time frame: Every 8 weeks
Toxicity According to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
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.
Time frame: 1st and 2nd week of each 21 day cycle, up to six cycles.
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