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

Not Applicable

Completed

• Conditions: Kidney Cancer
• Interventions: Drug: sunitinib malate; Procedure: neoadjuvant therapy; Procedure: therapeutic conventional surgery

• Registration Number: NCT00849186
• Lead Sponsor: Roswell Park Cancer Institute

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-23
• Primary Completion: 2009-07
• Study Completion: 2010-04
• Status Verified: 2015-01
• Results First Submitted: 2015-01-22
• Results First Submitted QC: 2015-01-22
• Last Update Submitted: 2015-01-22
• Results First Posted: 2015-02-06
• Last Update Posted: 2015-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	therapeutic conventional surgery	-
Arm 1	sunitinib malate	-
Arm 1	neoadjuvant therapy	-

Primary Outcome Measures

Name	Time	Method
Safety of Sunitinib Malate (SM)	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	90 days	Incident Rate: Intraoperative Complication Rate

Secondary Outcome Measures

Name	Time	Method
Response Rate After 90 Days of Treatment With SM	90 days

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States