High-dose Bevacizumab in Advanced Renal Carcinoma Patients

Completed · Phase 2

Conditions studied: Renal Cancer, Kidney Cancer

In brief

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.

Key facts

Study ID

NCT00455975

Run by

SCRI Development Innovations, LLC

People needed

119

Starts

2007-02-01

Expected to finish

2013-09-01

Last updated by the study team

2014-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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