Phase II Trial of High-Dose Bevacizumab in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma

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.