Bevacizumab (Avastin) and RAD001(Everolimus)in the Treatment of Advanced Clear Cell Renal Carcinoma

Inclusion Criteria

• •Histologically documented metastatic or unresectable locally recurrent clear cell renal carcinoma.
• •In patients with mixed histologies, the clear cell component must comprise ≥ 75% of the cancer
• •Previous nephrectomy is required with the following exceptions:
• •Primary tumor \< 5cm
• •Extensive liver ( \> 30% of liver parenchyma)or
• •Multiple (\> 5) bone metastases, making nephrectomy a clinically contraindicated procedure
• •Patients may have had a maximum of 1 previous systemic regimen for metastatic disease
• •Patients may not have received previous bevacizumab. However, patients who have received other agents with anti-angiogenic activity (eg. sorafenib, SU11248, AG-013736, PTK787, thalidomide) as part of first-line treatment are eligible
• •Patients may not have received previous treatment with m-TOR inhibitors.
• •ECOG performance status 0 or 1
• •Measurable disease
• •Adequate liver, kidney and bone marrow function
• •No previous systemic treatment or radiation therapy for at least 2 weeks prior to study entry
• •Patients must be able to understand the nature of this study and give written informed consent
• •Patients with proteinuria
• •Patients with any non-healing wound, ulcer, or long-bone fracture
• •Patients with any history of a bleeding diathesis or coagulopathy
• •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
• •Patients who have received any other experimental drug within 28 days of starting treatment
• •History of any other severe and/or uncontrolled medical disease
• •History of HIV infection
• •Chronic treatment with steroids or other immunosuppressive agents
• •Patients with impaired GI function that compromises the ability to swallow or absorb RAD001
• •Patients who are unwilling or unable to comply with the protocol