A Phase II Trial of Gemzar (Gemcitabine), Taxol (Paclitaxel), and Platinol (Cisplatin) (GTP) in Treatment of Advanced Transitional Cell Carcinoma of the Urothelium
- 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.
Masking: Open Label, Primary Purpose: Treatment
Frank M. Torti, MD, MPH
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
|Carolinas Hematology-Oncology Associates||Charlotte, North Carolina 28203|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Regional Cancer Center||Greensboro, North Carolina 27403-1199|