A Pilot Study of Neoadjuvant SUNITINIB MALATE (Sunitinib) in Patients With Renal Cell Carcinoma Undergoing Nephrectomy
- Determine the safety of sunitinib malate in patients with localized or metastatic renal
- Determine the safety of surgery after 90 days of treatment with sunitinib malate in
- Determine response of these patients after 90 days of treatment with sunitinib malate.
OUTLINE: Patients receive oral sunitinib malate once daily on days 1-90 in the absence of
disease progression or unacceptable toxicity. Patients then undergo radical nephrectomy.
After completion of study treatment, patients are followed for 3 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of sunitinib malate (SM)
Willie Underwood, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|