Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma

Inclusion Criteria: * Patients with advanced (unresectable, recurrent or metastatic) RCC * Patients reasonably likely to benefit from treatment with sorafenib as a single agent therapy * Patients with an ECOG performance status of 0-2 * Patients who will not require other systemic anticancer therapy (except for bisphosphonates) while taking sorafenib * Patients with vascular diseases such as wet macular degeneration, vasculitis, or new peptic ulcer, may be enrolled but require close monitoring in accordance with established medical practice Exclusion Criteria: * Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial * Patients who have participated in any other sorafenib trial * Patients who have had prior therapy with investigational agent(s) within the last four weeks prior to study entry * Life expectancy of less than two months * Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0 * Patients with active coronary artery disease or ischemia * Patients with Child-Pugh class C hepatic impairment * Patients with severe renal impairment or who require dialysis * Patients with active uncontrolled hypertension * Patients with recent or active bleeding diathesis