Status:
COMPLETED
High-dose Bevacizumab in Advanced Renal Carcinoma Patients
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Renal Cancer
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. T...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00455975
Start Date
February 1 2007
End Date
September 1 2013
Last Update
December 22 2014
Active Locations (13)
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1
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
2
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
3
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
4
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817