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A Phase II Study of Bevacizumab Plus Docetaxel and Gemcitabine in Subjects With Advanced, Previously Untreated, Non-Squamous 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. Drugs used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, 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 and gemcitabine hydrochloride may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and gemcitabine hydrochloride works in treating patients with stage IIIB, stage IV, or recurrent 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.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Fairview Hospital, Moll Pavilion
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Hillcrest Hospital, a Cleveland Clinic Hospital
Mayfield Heights, Ohio, United States
Start Date
September 1, 2009
Primary Completion Date
September 1, 2011
Completion Date
September 1, 2011
Last Updated
August 16, 2022
13
ACTUAL participants
bevacizumab
BIOLOGICAL
docetaxel
DRUG
gemcitabine hydrochloride
DRUG
Lead Sponsor
Nathan Pennell, MD, PhD
Collaborators
NCT06305754
NCT06498635
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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