Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This clinical trial is studying the side effects of giving sunitinib before surgery and to see how well it works in treating patients with localized or metastatic kidney cancer.
Drug: sunitinib malate
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Neoadjuvant SUNITINIB MALATE (Sunitinib) in Patients With Renal Cell Carcinoma Undergoing Nephrectomy|
- Safety of Sunitinib Malate (SM) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment.
- Safety of Surgery After 90 Days of Treatment With SM [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]Incident Rate: Intraoperative Complication Rate
- Response Rate After 90 Days of Treatment With SM [ Time Frame: 90 days ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||April 2010|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
|Experimental: Arm 1||
Drug: sunitinib malate
oralProcedure: neoadjuvant therapy
IVProcedure: therapeutic conventional surgery
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849186
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Willie Underwood, MD||Roswell Park Cancer Institute|