Sorafenib in Treating Patients Who Are Undergoing Surgery for Metastatic Kidney Cancer

PRIMARY OBJECTIVES: I. Efficacy of BAY 43-9006 (sorafenib tosylate) by evaluating response rate. II. Toxicities of BAY 43-9006 in metastatic renal cell carcinoma (RCC). III. Intraoperative and peri/postoperative safety of BAY 43-9006. SECONDARY OBJECTIVES: I. Time to progression. II. Duration of response. II. Overall Survival. TERTIARY OBJECTIVES: I. Tissue expression of VEGFR-2/phospho-VEGFR-2, PDGFR/phospho-PDGFR, FGFR/phospho-FGFR, ERK/phospho-ERK, RAF-1/phospho-RAF-1, p38/phospho-p38, Akt/phospho-Akt, P27, Ki67, TGF-alpha, and TUNEL pre- and post- therapy (optional studies). II. Oligonucleotide analysis of tissue pre- and post-therapy (optional studies). OUTLINE: This is a non-randomized study. Patients are sequentially assigned to 1 of 3 treatment groups. GROUP I: Patients undergo cytoreductive nephrectomy on day 1. Patients then receive oral sorafenib twice daily on days 15-84. GROUP II: Patients receive oral sorafenib twice daily on days 1-7. Patients undergo cytoreductive nephrectomy on day 8. Patients then receive oral sorafenib twice daily on days 22-84. GROUP III: Patients receive oral sorafenib twice daily on days 1-28. Patients undergo cytoreductive nephrectomy on day 29. Patients then receive oral sorafenib twice daily on days 43-84. In all groups, patients with stable or regressing disease continue to receive oral sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Some patients may continue treatment for longer than 1 year at the discretion of the investigator. After completion of study treatment, patients are followed every 2 months. PROJECTED ACCRUAL: A total of 45 patients (15 per treatment group) will be accrued for this study within 1 year.