This phase II trial will evaluate the combination of bevacizumab + RAD001 in patients with metastatic renal cell carcinoma. In this trial the investigators will evaluate this combination in patients previously untreated with any anti-angiogenesis agent and patients who have previously received one prior regimen containing an anti-angiogenesis agent.
All eligible patients will receive: * Bevacizumab 10mg/kg, IV infusion, every 2 weeks * RAD001 10 mg by mouth daily All patients will be evaluated for response after completing two courses (8 weeks) of treatment. Patients with objective tumor response or stable disease will continue treatment with bevacizumab adn RAD001 on the same schedule. Treatment will continue until disease progression occurs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Bevacizumab 10mg/kg, IV infusion, every 2 weeks
RAD001 10 mg by mouth daily
Florida Cancer Specialists
Fort Myers, Florida, United States
Gainsville Hematology Oncology Associates
Gainesville, Florida, United States
Integrated Community Oncology Network
Jacksonville, Florida, United States
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
Time frame: 18 months
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Time frame: 18 months
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Florida Hospital Cancer Institute
Orlando, Florida, United States
Wellstar Cancer Research
Marietta, Georgia, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Methodist Cancer Center
Omaha, Nebraska, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
...and 2 more locations