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