High-dose Bevacizumab in Advanced Renal Carcinoma Patients

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborator: Genentech, Inc.
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.