Bladder Cancer Clinical Trial
Official title:
A Multicentre Phase II Trial to Determine the Efficacy of the Anti-Tyrosine Kinase Sunitinib (Sutent®) as Second Line Therapy in Patients With Transitional Cell Carcinoma (TCC) of the Urothelium Which Failed or Progressed After First Line Chemotherapy for Advanced or Metastatic Disease
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying sunitinib to see how well it works as second-line
therapy in treating patients with locally advanced or metastatic transitional cell cancer.
OBJECTIVES:
Primary
- To determine the objective tumor response rate according to RECIST criteria in patients
with locally advanced or metastatic transitional cell carcinoma of the urothelium
treated with sunitinib malate who failed or progressed after first-line chemotherapy .
Secondary
- To determine the safety of this drug.
- To determine the time to response and duration of response.
- To determine the progression-free survival and overall survival of these patients.
- To evaluate the quality of life of these patients.
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate once daily for 4 weeks. Courses repeat every 6 weeks
for 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 2 months.
;
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
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