Kidney Cancer Clinical Trial
Official title:
A Phase II Study of Sunitinib Malate in Patients With Renal Cell Carcinoma and Unresectable Primary Tumors
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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