Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase II Trial of Bevacizumab in Patients With Recurrent Solid Tumor Brain Metastases Who Have Failed Whole Brain Radiation Therapy
This is a study to evaluate a drug called bevacizumab in patients with cancer whose disease has spread to their brain. This study will not evaluate the effect of bevacizumab on the systemic solid tumor cancer. Bevacizumab is a medication and it is thought that bevacizumab may interfere with the growth of new blood vessels; therefore it might stop tumor growth and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels.
PRIMARY OBJECTIVES:
I. Determine the radiographic response rate in patients with solid tumor brain metastases
treated with bevacizumab.
SECONDARY OBJECTIVES:
I. Estimate the progression-free survival (PFS) rate at 6 months. II. Determine the time to
progression based on magnetic resonance imaging (MRI) or computed tomography (CT) scans.
III. Determine the time to response based on radiographic imaging. IV. Determine the duration
of response based on radiographic imaging. V. Determine overall survival. VI. Collect
additional safety data. VII. Assess changes in quality of life using the Functional
Assessment of Cancer Therapy-Brain (FACT-Br) while on treatment.
OUTLINE:
Patients receive bevacizumab intravenously (IV) over 30-90 minutes every 2 weeks. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 8 weeks.
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