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
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.
Interventional
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Objective response as assessed by RECIST criteria
No
Christine Theodore, MD
Principal Investigator
Hopital Foch
United States: Federal Government
CDR0000618219
NCT00792025
December 2008
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