Bladder Cancer Clinical Trial
Official title:
A Phase II Study Assessing SU-011248 in Previously Untreated Patients With Advanced Urothelial Cancer Ineligible for Cisplatin-Based Chemotherapy
RATIONALE: Sunitinib malate 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 the side effects of giving sunitinib malate and to
see how well it works in treating patients with locally recurrent, locally advanced,
unresectable, or metastatic urinary tract cancer.
OBJECTIVES:
Primary
- To determine the time to disease progression (defined as the time from diagnosis of
metastatic urothelial carcinoma until first confirmed progression of the disease) in
patients with locally recurrent, locally advanced, unresectable, or metastatic
urothelial cancer treated with sunitinib malate and ineligible for cisplatin-based
chemotherapy.
- To determine the safety of this drug in these patients.
Secondary
- To determine the progression-free survival of patients treated with this drug.
- To determine the overall response rate in patients treated with this drug.
- To determine the overall survival of patients treated with this drug.
- To determine the time to treatment failure in patients treated with this drug.
- To determine the pharmacodynamic profile of this drug in pre- and post-treatment serum
and tumor tissue (i.e., IL8, VEGF, MMP9, bFGF, p27, Ki-67, and apoptosis [H/E]) at week
6, and if possible, at time of progression.
- To determine the quality of life of patients treated with this drug using the QLQ-C30
version 3 questionnaire.
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6
weeks in the absence of disease progression or unacceptable toxicity.
Patients complete quality-of-life questionnaire (EORTC QLQ-C30) before, during, and at the
end of study treatment.
Serum and tumor tissue samples are collected at baseline and after study treatment for
pharmacodynamic studies. Samples are analyzed for markers (i.e., IL8, VEGF, MMP9, bFGF, p27,
Ki-67, and apoptosis [H/E]) via immunohistochemistry.
After completion of study treatment, patients are followed for 28 days and then every 2
months for up to 3 years.
;
Masking: Open Label, Primary Purpose: Treatment
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