Bladder Cancer Clinical Trial
Official title:
A Phase II Trial of Gemzar (Gemcitabine), Taxol (Paclitaxel), and Platinol (Cisplatin) (GTP) in Treatment of Advanced Transitional Cell Carcinoma of the Urothelium
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and cisplatin, work
in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill
more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel
and cisplatin works in treating patients with advanced transitional cell cancer of the
urothelium.
OBJECTIVES:
- Determine response to gemcitabine hydrochloride, paclitaxel, and cisplatin (GTP) among
patients with regional or distant metastases of transitional cell carcinoma of the
urothelium or local/regional recurrence after cystoprostatectomy.
- Determine response in patients who receive GTP as the initial chemotherapeutic treatment
as well as in patients who have received prior chemotherapy.
- Determine response duration, freedom from progression, and overall survival.
- Assess the toxicity of GTP.
OUTLINE: This is an open-label study. Patients are stratified according to prior chemotherapy
(yes vs no).
Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and
gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days
for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients achieving a partial response or complete response undergo surgical restaging and
debulking. Four to 6 weeks later, patients receive 2 additional courses of chemotherapy.
After completion of study treatment, patients are followed every 3 months for 1 year and then
every 6 months thereafter.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.
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