Stage IV Bladder Cancer Clinical Trial
Official title:
A Phase II Safety and Efficacy Study With the VEGF Receptor Tyrosine Kinase Inhibitor GW786034 in Patients With Metastatic Urothelial Cancer
This phase II trial is studying the side effects and how well pazopanib works in treating patients with metastatic urothelial cancer. Pazopanib 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.
PRIMARY OBJECTIVES:
I. Assess the anti tumor activity and toxicity profile of pazopanib hydrochloride in
patients with metastatic urothelial cancer.
SECONDARY OBJECTIVES:
I. Evaluate the pharmacokinetics of pazopanib hydrochloride in these patients. II. Evaluate
pre- and post-treatment changes in circulating endothelial cells, monocytes and platelets,
and angiogenesis-related factors in these patients.
OUTLINE: This is a multicenter study. Patients receive oral pazopanib hydrochloride once
daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.
Patients undergo blood collection periodically for correlative studies and pharmacological
studies. Samples are analyzed for vascular endothelial growth factor (VEGF) and soluble VEGF
receptor II concentration via ELISA. Circulating endothelial cells are also measured.
After completion of study treatment, patients are followed for 1 year.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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