Pazopanib in Treating Patients With Metastatic Urothelial Cancer

Completed · Phase 2

Conditions studied: Distal Urethral Cancer, Proximal Urethral Cancer, Recurrent Bladder Cancer, Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Urethral Cancer, Stage IV Bladder Cancer, Transitional Cell Carcinoma of the Bladder, Urethral Cancer Associated With Invasive Bladder Cancer

In brief

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.

Key facts

Study ID

NCT00471536

Run by

National Cancer Institute (NCI)

People needed

19

Starts

2008-08-01

Expected to finish

2013-12-01

Last updated by the study team

2014-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed transitional cell cancer of the urothelium or bladder
• Metastatic disease
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
• No known brain metastases
• ECOG performance status 0-2
• Life expectancy ≥ 12 weeks
• Platelet count ≥ 100,000/mm\^3
• WBC ≥ 3,000/mm\^3
• Absolute neutrophil count ≥ 1,500/mm\^3
• Bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• PT/INR/PTT ≤ 1.2 times ULN
• No proteinuria > 1+ on two consecutive dipsticks measured ≥ 1 week apart
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or other agents used in the study
• No condition that impairs the ability to swallow and retain pazopanib hydrochloride tablets, including any of the following:
• Gastrointestinal tract disease resulting in an inability to take oral medication
• Requirement for IV alimentation
• Prior surgical procedures affecting absorption
• Active peptic ulcer disease
• No uncontrolled illness that would limit compliance with study therapy including, but not limited to, any of the following:
• Ongoing or active infection

Where it is running

• 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

Full record on ClinicalTrials.gov

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