A Phase II Study of Sunitinib Malate in Patients With Renal Cell Carcinoma and Unresectable Primary Tumors
- 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
- 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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response to sunitinib therapy
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
1 year from start of treatment
Brian I. Rini, MD
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|