Sorafenib and RAD001 Renal Cell Carcinoma

Exclusion Criteria

• •1. Collecting duct, papillary, or chromophobe type renal cell carcinoma without a clear cell component are excluded. Transitional cell carcinoma of the renal pelvis is excluded
• •2. No more than two prior systemic regimens for renal cell carcinoma
• •3. Phase I: No prior treatment with sorafenib. Phase II: No prior treatment with prior anti-VEGF therapies, including sorafenib, sunitinib, thalidomide, or bevacizumab
• •4. No prior treatment with RAD001, CCI-779, or similar agents
• •5. Prior surgery, radiation therapy, or systemic therapy for renal cell carcinoma within 4 weeks of starting study treatment
• •6. History of or known brain metastasis, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening CT or MRI scan
• •7. Any of the following within 12 months prior to study drug administration: myocardial infarction, unstable or severe angina, coronary or peripheral artery bypass graft, NYHA functional Class II, III, IV congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
• •8. Hypertension that is unable to be controlled with medications
• •9. Known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness
• •10. "Currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered to have a less than 30% risk of relapse
• •11. Current treatment on another clinical trial
• •12. Pregnant or breastfeeding
• •13. Chronic treatment with systemic steroids or other immunosuppressive agent
• •14. Patients with an active bleeding diathesis or on oral vitamin K antagonist medication (except low dose warfarin)
• •15. History of malabsorption syndrome, disease significantly affecting gastrointestinal function or major resection of stomach or small bowel that could interfere with absorption, distribution, metabolism, or excretion of study drugs
• •16. Any serious and/or unstable pre-existing medical, psychiatric, or other condition (including lab abnormalities) that could interfere with subject safety or obtaining informed consent. Examples of such include uncontrolled diabetes, nonhealing wound, severe infection, severe malnutrition, ventricular arrhythmias, active ischemic heart disease, chronic liver or renal disease, or active upper GI tract ulceration -