Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00849186|
Recruitment Status : Completed
First Posted : February 23, 2009
Results First Posted : February 6, 2015
Last Update Posted : February 6, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: sunitinib malate Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Neoadjuvant SUNITINIB MALATE (Sunitinib) in Patients With Renal Cell Carcinoma Undergoing Nephrectomy|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||April 2010|
|Experimental: Arm 1||
Drug: sunitinib malate
oralProcedure: neoadjuvant therapy
IVProcedure: therapeutic conventional surgery
- Safety of Sunitinib Malate (SM) [ Time Frame: 90 days ]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 ]Incident Rate: Intraoperative Complication Rate
- Response Rate After 90 Days of Treatment With SM [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|