NCT00849186

Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer

A Pilot Study of Neoadjuvant SUNITINIB MALATE (Sunitinib) in Patients With Renal Cell Carcinoma Undergoing Nephrectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
DRUG	sunitinib malate	oral
PROCEDURE	neoadjuvant therapy	IV
PROCEDURE	therapeutic conventional surgery	Surgery

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-07-01
• Completion: 2010-04-01
• First posted: 2009-02-23
• Last updated: 2015-02-06
• Results posted: 2015-02-06

Locations

1 site across 1 country: United States