NCT00459979

Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by Surgery

A Phase II Study of Sunitinib Malate in Patients With Renal Cell Carcinoma and Unresectable Primary Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Sunitinib may stop the growth of kidney cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects and how well sunitinib works in treating patients with kidney cancer that cannot be removed by surgery.

Detailed description

OBJECTIVES: * To determine the percentage of patients with renal cell carcinoma and unresectable primary tumors who can achieve sufficient tumor response, according to the operating surgeon, to undergo nephrectomy after sunitinib therapy. * To evaluate the safety of sunitinib in patients with renal cell carcinoma and unresectable primary tumors, including analysis of the morbidity of surgery after sunitinib therapy * To evaluate the objective response rate of patients with renal cell carcinoma and unresectable primary tumors who receive sunitinib therapy. OUTLINE: A single arm phase II study of sunitinib in patients with unresectable renal cell carcinoma (RCC) will be conducted, including patients with and without distant metastases. Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity. Surgery is performed if and when primary tumor becomes resectable. Patients with residual and/or metastatic disease may resume sunitinib malate within 8 weeks after surgery. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 31 patients will be accrued for this study.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
DRUG	sunitinib malate	Sunitinib will be dosed at 50 mg p.o. daily
PROCEDURE	conventional surgery	nephrectomy

Timeline

• Start date: 2007-03-01
• Primary completion: 2011-03-01
• Completion: 2013-09-01
• First posted: 2007-04-13
• Last updated: 2014-03-07
• Results posted: 2014-01-07

Locations

1 site across 1 country: United States