Phase I/II Trial of Sorafenib (Nexavar) and RAD001 (Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma

Inclusion Criteria:

- Clinically documented metastatic or unresectable locally recurrent clear cell renal
carcinoma

- Previous removal of kidney except if the size of the tumor was less than 5 cm or
there was extensive liver or bone metastasis

- May have had no prior chemotherapy or up to 1 prior treatment regimen with
immunotherapy or chemotherapy

- Performance status of 0-1

- Measurable disease

- Adequate liver, renal, and bone marrow function

- Must be able to give written informed consent

- Women able to become pregnant must have a negative pregnancy test

- Must be 18 or over

- Must be able to swallow pills

Exclusion Criteria:

- Prior treatment with sorafenib or m-TOR inhibitors

- History of acute MI within the last 6 months

- Active brain metastasis or patients with meningeal metastases

- Prior treatment for another cancer in the last 5 years

- Prior bleeding problems; coughing up or vomiting blood

- Non-healing wounds, ulcer, or long bone fracture

- Chronic use of systemic steroids or immunosuppressive agents

- Uncontrolled hypertension

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.