A Pilot Study of Neoadjuvant SUNITINIB MALATE (Sunitinib) in Patients With Renal Cell Carcinoma Undergoing Nephrectomy
OBJECTIVES:
Primary
- Determine the safety of sunitinib malate in patients with localized or metastatic renal
cell carcinoma.
- Determine the safety of surgery after 90 days of treatment with sunitinib malate in
these patients.
Secondary
- 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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of sunitinib malate (SM)
90 days
Yes
Willie Underwood, MD
Principal Investigator
Roswell Park Cancer Institute
United States: Food and Drug Administration
CDR0000634770
NCT00849186
August 2007
April 2010
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |