High-dose Bevacizumab in Advanced Renal Carcinoma Patients
NCT ID: NCT00455975
Last Updated: 2014-12-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
119 participants
INTERVENTIONAL
2007-02-28
2013-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Weekly Avastin
Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity
Bevacizumab
Bevacizumab
Bi-weekly Avastin
Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
Bevacizumab
Bevacizumab
Interventions
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Bevacizumab
Bevacizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
SCRI Development Innovations, LLC
OTHER
Responsible Party
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Principal Investigators
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John D. Hainsworth, M.D.
Role: STUDY_CHAIR
SCRI Development Innovations, LLC
Locations
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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
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
Family Cancer Center
Collierville, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Peninsula Cancer Institute
Newport News, Virginia, United States
Countries
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Other Identifiers
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AVF 3913s
Identifier Type: -
Identifier Source: secondary_id
SCRI GU 43
Identifier Type: -
Identifier Source: org_study_id