Phase I/II Trial of Sequential Doxorubicin/Gemcitabine (AG) and Ifosfamide, Paclitaxel, and Cisplatin (ITP) Chemotherapy (AG-ITP) in Patients With Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium
- Determine the safety and toxicity of doxorubicin, gemcitabine, and filgrastim (G-CSF)
followed by ifosfamide, paclitaxel, cisplatin, and G-CSF in patients with metastatic or
locally advanced transitional cell carcinoma of the urothelium.
- Determine the efficacy of this regimen in this patient population.
OUTLINE: This is a dose-escalation study of gemcitabine.
Patients receive doxorubicin IV over 30 minutes and gemcitabine IV on day 1 and filgrastim
(G-CSF) subcutaneously (SC) on days 3-11. Treatment repeats every 2 weeks for 5 courses.
After completion of the fifth course, patients receive paclitaxel IV over 3 hours and
cisplatin IV over 1 hour on day 1, ifosfamide IV over 1 hour on days 1-3, and G-CSF SC daily
on days 6-17. Treatment repeats every 3-4 weeks for 4 courses.
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 3
of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional
patients are treated at the MTD.
PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for phase I and a maximum of 10
patients will be accrued for phase II within 2-3 years.
Primary Purpose: Treatment
Dean F. Bajorin, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
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