Stage IV Bladder Cancer Clinical Trial
Official title:
A Phase II Study of VEGF Trap (NSC 724770) in Patients With Recurrent or Metastatic Transitional Carcinoma of the Urothelium
This phase II trial is studying the side effects and how well VEGF Trap works in treating patients with recurrent, locally advanced, or metastatic cancer of the urothelium. VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor.
PRIMARY OBJECTIVES:
I. Determine the response rate in patients with recurrent, locoregionally advanced, or
metastatic transitional cell carcinoma of the urothelium treated with VEGF Trap.
II. Determine the time to progression in patients treated with this drug. III. Determine
overall survival of patients treated with this drug. IV. Determine the tolerability and
safety of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the
absence of disease progression or unacceptable toxicity.
Patients undergo blood collection periodically during study for
pharmacokinetic/pharmacodynamic correlative studies.
After completion of study treatment, patients are followed periodically.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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