Phase II Single Arm, Open Label, Single Institution Study of Neoadjuvant Sunitinib (SUTENT) in Patients With Muscle-Invasive Locally Advanced Transitional Cell Carcinoma of the Bladder
- To determine the pathologic complete response rate of sunitinib malate in patients with
muscle-invasive locally advanced transitional cell carcinoma (TCC) of the bladder.
- To evaluate the safety and tolerability of sunitinib malate administered prior to
radical cystectomy, including surgical outcome and surgical complications.
- To determine the clinical effects of sunitinib malate administered prior to radical
cystectomy and bilateral lymph node dissection, including overall response rate using
RECIST defined criteria, cytology, and histologic appearance of surgical specimen as
well as time to progression.
- 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 neoadjuvant sunitinib malate.
- To evaluate the effects of sunitinib malate on immunosuppressive regulatory T cells.
OUTLINE: Patients receive oral sunitinib malate once daily in weeks 1-4 (1 course). Patients
undergo restaging within 1 week prior to surgery and then undergo radical cystectomy and
bilateral lymph node dissection on day 42. Patients achieving a complete pathologic response
at the time of surgery may receive 6 more courses of adjuvant sunitinib malate beginning 28
days after surgery at the discretion of the treating physician. Patients found to have
high-risk features (i.e. pT3 or greater tumor and evidence of disease in any of the lymph
nodes resected) are offered standard adjuvant systemic chemotherapy at the discretion of the
Tumor tissue from pretreatment biopsy and radical cystectomy will be tested for VEGFR-1,
VEGFR-2 and PDGF-R expression by IHC. Samples are also analyzed for quantification of cell
proliferation and apoptosis and immunosuppressive regulatory T cells (T-reg) and T-reg
After completion of study treatment, patients are followed at 28 days after surgery.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathologic Complete Response Rate of Sunitinib
Evaluate the clinical activity of Sunitinib (Sutent®) given prior to radical cystectomy. Sunitinib will be 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks. Day 35: re-staging CT scans prior to surgery to capture any potential changes in cytology and cystoscopic examination will be performed.
at 6 weeks
Jorge A. 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|