Spots Global Cancer Trial Database for Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer

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Trial Identification

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

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

Study ID: NCT00849186

Conditions

Kidney Cancer

Interventions

sunitinib malate

neoadjuvant therapy

therapeutic conventional surgery

Study Description

Brief 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.