High-dose Bevacizumab in Advanced Renal Carcinoma Patients
- Registration Number
- NCT00455975
- Lead Sponsor
- SCRI Development Innovations, LLC
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
- Histologically documented metastatic or unresectable locally recurrent clear cell renal carcinoma
- Previous kidney removal is required except if the primary tumor was smaller than 5 cm or there was extensive liver or bone metastasis
- Patients may have received a maximum of 1 prior systemic treatment of immunotherapy (Interferon, IL-2), chemotherapy, or combination chemo+immunotherapy for metastatic disease.
- No prior bevacizumab
- Measurable disease
- Adequate liver and kidney function
- Age 18 and older
- Acute MI within the past 6 months
- Uncontrolled high blood pressure or history of hypertensive crisis
- Clinically significant cardiovascular disease
- Active brain cancer
- Meningeal metastasis
- Pregnant or lactating women
- Prior treatment for another cancer less than 5 years ago
- No diseases of the central nervous system (eg. uncontrolled seizures, strokes or TIAs
- No bleeding from the mouth, rectum or coughing up blood or history of other bleeding or clotting disorders
- No history of deep vein thrombosis less than 12 months ago or are currently requiring full dose anticoagulation
- No major surgical procedures, open biopsies or traumatic injury in past 28 days
- No patients with peg tubes or feeding tubes
- No patients with non healing wounds, ulcers or long bone fractures
- No history of abdominal fistulas, gastrointestinal perforation or intrabdominal abscess within 6 months
- No symptomatic peripheral vascular disease
Please note: there are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Weekly Avastin Bevacizumab Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity Bi-weekly Avastin Bevacizumab Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
- Primary Outcome Measures
Name Time Method Progression-free Survival 18 months (expected) 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
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) 18 months Measured from date of study entry to date of death due to any cause.
Overall Tolerability and Toxicity of High-dose Bevacizumab 18 months Number of patients treated with high-dose bevacizumab experiencing Grade 3/4, treatment-related toxicities
Objective Response Rate 18 months 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
Trial Locations
- Locations (13)
Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
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
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
Family Cancer Center
🇺🇸Collierville, Tennessee, United States
Peninsula Cancer Institute
🇺🇸Newport News, Virginia, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Methodist Cancer Center
🇺🇸Omaha, Nebraska, United States