This trial will examine the effectiveness and the side effects of 2 higher dosing schedules of bevacizumab in patients that have advanced clear cell renal carcinoma.
Bevacizumab is considered a targeted drug. Targeted drugs act on specific receptors on a cell. Bevacizumab blocks receptors that help cancer cells develop blood supplies so that the cancer can grow. These specific receptors are found in greater numbers in kidney cancer. In that regard bevacizumab will be tested in 2 doses that are higher than non-kidney cancer treatments with bevacizumab. One group of patients will receive bevacizumab at 15 mg per kg by vein every 2 weeks. A total of 75 patients will be treated with this dose. If this dose is well tolerated a second group of patients will receive bevacizumab at 15mg per kg by vein weekly.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
119
Bevacizumab
Florida Cancer Specialists
Fort Myers, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Progression-free Survival
Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: 18 months (expected)
Overall Survival (OS)
Measured from date of study entry to date of death due to any cause.
Time frame: 18 months
Objective Response Rate
The number of patients with observed complete response \[CR\] or partial response \[PR\]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR
Time frame: 18 months
Overall Tolerability and Toxicity of High-dose Bevacizumab
Number of patients treated with high-dose bevacizumab experiencing Grade 3/4, treatment-related toxicities
Time frame: 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Methodist Cancer Center
Omaha, Nebraska, United States
Cancer Care of Western North Carolina
Asheville, North Carolina, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States
...and 3 more locations