Bladder Cancer Clinical Trial
Official title:
Phase 2 Study With the Multi-Targeted Tyrosine-Kinase Inhibitor Pazopanib (GW786034) for Patients With Relapsed or Refractory Urothelial Cancer
RATIONALE: Pazopanib hydrochloride 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.
PURPOSE: This phase II trial is studying how well pazopanib hydrochloride works in treating
patients with or metastatic urothelial cancer or bladder cancer that has relapsed or not
responded to treatment.
OBJECTIVES:
Primary
- To evaluate the activity of daily oral doses of pazopanib hydrochloride monotherapy in
patients with relapsed/refractory metastatic urothelial carcinoma or transitional cell
tumors.
Secondary
- To evaluate the safety and tolerability of pazopanib hydrochloride monotherapy in a
population of chemotherapy pretreated patients.
- To assess progression-free survival of these patients.
Tertiary
- To evaluate the ability of whole-body 18FDG-PET to image metastases and monitor tumor
response and to determine the rate of concordance with CT imaging and RECIST response
criteria.
- To evaluate the relationship existing between tumor response measured by 18FDG-PET and
progression-free survival.
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 whole-body 18FDG-PET at baseline and periodically.
After completion of study treatment, patients are followed for 2 years.
;
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
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