A Phase II Study of Bevacizumab Plus Docetaxel and Gemcitabine in Subjects With Advanced, Previously Untreated, Non-Squamous Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- Estimate the 1-year progression-free survival rate in patients with stage IIIB, stage
IV, or recurrent non-squamous cell non-small cell lung cancer treated with bevacizumab,
docetaxel, and gemcitabine hydrochloride.
Secondary
- Evaluate the median time to progression in patients treated with this regimen.
- Estimate the response rate in patients treated with this regimen.
- Determine the median overall survival of patients treated with this regimen.
- Determine the incidence of adverse events associated with this regimen in these
patients.
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes and docetaxel IV over 60 minutes
on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats
every 21 days for up to 6 courses in the absence of disease progression or unacceptable
toxicity. Patients with responsive or stable disease may then continue to receive
bevacizumab alone for up to 12 months in the absence of disease progression.
After completion of study treatment, patients are followed up every 3 months.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
Progression free survival
1 year
No
Nathan Pennell, MD, PhD
Principal Investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
CASE4507
NCT00970684
September 2009
November 2013
Name | Location |
---|---|
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |
Fairview Hospital, Moll Pavilion | Cleveland, Ohio 44111 |
Hillcrest Hospital, a Cleveland Clinic Hospital | Mayfield Heights, Ohio 44124 |