High-dose Bevacizumab in Advanced Renal Carcinoma Patients

• Side effects of treatment will be evaluated at each patient visit
• Effectiveness of the treatment will be measured by periodic tests/scans

• overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
• objective response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
• overall tolerability and toxicity of high-dose bevacizumab [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  the treatment of patients with renal cell carcinoma

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.

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. These specific receptors are found in greater numbers in kidney cancer. In that regard bevacizumab will be tested in 2 doses that are higher than non-kidney cancer treatments with bevacizumab.

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.

• Renal Cancer
• Kidney Cancer

• pts 61-120 receive weekly avastin
  Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity
  Intervention: Drug: Bevacizumab
• 1st 60 pts receive Bi-weekly Avastin
  Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity
  Intervention: Drug: Bevacizumab

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.