Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer

Transitional Cell Carcinoma of the Bladder Clinical Trial

Official title: 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

Status Terminated

Clinical Trial Summary

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients with recurrent transitional cell bladder cancer.

Clinical Trial Description

PRIMARY OBJECTIVES:

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 intravesical BCG.

SECONDARY OBJECTIVES:

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.

TERTIARY OBJECTIVES:

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 (Tregs).

III. To determine the presence of circulating tumor cells in superficial BCG-refractory TCC patients.

OUTLINE:

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. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Recurrent Bladder Cancer
• Transitional Cell Carcinoma of the Bladder
• Urinary Bladder Neoplasms

• NCT number: NCT01118351
• Study type: Interventional
• Source: Case Comprehensive Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: October 2008
• Completion date: September 2015