Phase II Single Arm, Open Label, Single Institution Study of Continuous Sunitinib (Sutent) in Patients With High-Risk (BCG-Refractory) Superficial Transitional Cell Carcinoma (TCC) of the Bladder
I. To determine the clinical efficacy of oral sunitinib (Sutent) given continuously for a
maximum of 12 weeks, with respect to complete response rates at 12 months after completion
of treatment in patients with high-risk superficial bladder cancer who have failed previous
I. To assess the impact of sunitinib treatment in recurrence-free survival, progression-free
survival, and overall survival in patients with high-risk superficial TCC of the bladder who
have failed previous intravesical BCG.
II. To evaluate the safety and tolerability of sunitinib (Sutent) administered in patients
with high-risk superficial TCC of the bladder who have failed previous intravesical BCG.
I. To assess pre-treatment tissue baseline angiogenic markers and to evaluate the magnitude
of the difference among these variables with post-treatment tumor tissue after treatment
with sunitinib (Sutent).
II. To evaluate the effects of Sunitinib (Sutent) on immunosuppressive regulatory T cells
III. To determine the presence of circulating tumor cells in superficial BCG-refractory TCC
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28
days for 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response rate
Negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology 12 months after treatment with sunitinib.
At 12 months
Jorge Garcia, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|
|CCF-Fairview Hospital||Cleveland, Ohio 44111|