Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by Surgery
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.
Drug: sunitinib malate
Procedure: conventional surgery
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Sunitinib Malate in Patients With Renal Cell Carcinoma and Unresectable Primary Tumors|
- Response to sunitinib therapy [ Time Frame: 1 year from start of treatment ] [ Designated as safety issue: No ]Defined as a reduction in tumor burden to such an extent that nephrectomy is permitted within 1 year of the start of therapy. No response to sunitinib therapy is defined as a nephrectomy not being permitted within 1 year of the start of therapy or removal from the study for any reason
- The number of patients with any type of complication or adverse event [ Time Frame: within 1 year of the start of therapy ] [ Designated as safety issue: Yes ]The safety of sunitinib will be assessed by recording the number of patients with any type of complication or adverse event within 1 year of the start of therapy.
- Duration of overall response [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The duration of overall response is measured from the time measurement criteria are met for Complete Response(CR) or (Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented.
Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started.
|Study Start Date:||March 2007|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Drug: sunitinib malate
Sunitinib will be dosed at 50 mg p.o. daily
Other Names:Procedure: conventional surgery
- 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: Patients are stratified according to the presence of distant metastases (yes vs no).
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 62 patients will be accrued for this study.
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Brian I. Rini, MD||Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center|