NCT00397488

Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium

Phase II Study of Sunitinib in Metastatic Transitional Cell Carcinoma of the Urothelium

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with progressive metastatic transitional cell cancer of the urothelium.

Detailed description

OBJECTIVES: Primary * Determine the response rate in patients with progressive metastatic transitional cell carcinoma of the urothelium treated with sunitinib malate. * Determine the safety of this regimen in these patients. Secondary * Determine the time to disease progression in patients treated with this regimen. * To determine time to tumor progression (TTP) for sunitinib malate on a continuous dosing schedule for treatment of metastatic urothelial carcinoma. * To estimate sunitinib and SU012662 trough plasma concentration (Ctrough) data for the continuous daily schedule and to determine potential association with efficacy and safety.

Conditions

• Bladder Cancer
• Transitional Cell Cancer of the Renal Pelvis and Ureter
• Urethral Cancer

Interventions

Type	Name	Description
DRUG	sunitinib malate

Timeline

• Start date: 2006-09-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2006-11-09
• Last updated: 2016-01-25
• Results posted: 2016-01-25

Locations

1 site across 1 country: United States