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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic in Florida
Jacksonville, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
Wayne State University
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States
Cox Medical Center
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Chinese University of Hong Kong-Prince of Wales Hospital
Shatin, Hong Kong, China
Gangnam Severance Hospital
Seoul, South Korea
Start Date
August 1, 2008
Primary Completion Date
July 1, 2010
Completion Date
December 1, 2013
Last Updated
May 30, 2014
19
ACTUAL participants
pazopanib hydrochloride
DRUG
Lead Sponsor
National Cancer Institute (NCI)
NCT01846520
NCT00004856
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