Research Study for Patients With Metastatic Renal Cell Carcinoma

A Phase II Study of BAY 43-9006 Prior to and Following Nephrectomy in Patients With Metastatic Renal Cell Carcinoma.

This study has been designed to study patients diagnosed with advanced renal cell cancer with the primary tumor in place.

Inclusion Criteria:

• Life expectancy of at least 12 weeks
• Clinical, radiographic, or pathologic diagnosis of metastatic renal cell carcinoma (RCC). All renal cell histologies are allowed- Acceptable surgical risk in the judgment of the study investigator and consulting urological surgeon
• At least one uni-dimensional measurable lesion outside the planned nephrectomy specimen
• Patients who have an ECOG performance status of 0 or 1 Exclusion Criteria:
• History of bleeding diathesis or unexpected surgical bleeding- Patients currently receiving treatment with or having a requirement for therapeutic anticoagulation
• Prior therapy for RCC. Palliative radiation therapy for painful or unstable bone metastases is permitted provided that there is measurable metastatic disease outside the radiation field
• Known history of HIV infection- Symptomatic metastatic brain or meningeal tumors, unless the patient is > 6 months from definitive therapy, has a CT or MRI scan within 6 weeks of study entry negative for brain metastases and is clinically stable with respect to the tumor at the time of study entry