Sequential Gemcitabine, Doxorubicin, Then Paclitaxel Plus Cisplatin Adjuvant Chemotherapy After Complete Resection of Locally Advanced Transitional Cell Carcinoma of the Urothelium
OBJECTIVES: I. Determine the safety and toxicity of sequential dose intensive adjuvant
systemic therapy consisting of gemcitabine, then doxorubin, followed by paclitaxel and
cisplatin with filgrastim (granulocyte colony stimulating factor; G-CSF) for patients with
completely resected, locally advanced transitional cell carcinoma of the urothelium. II.
Assess the disease free and overall survival of these patients.
OUTLINE: Patients receive gemcitabine IV on weeks 1, 2, 3, 5, 6, and 7 for a total of 6
doses. A 1 week rest period occurs after the third dose of gemcitabine. At least 14 days
after the last dose of gemcitabine, during the ninth week, patients receive doxorubicin at 2
week intervals (weeks 9, 11, 13, and 15) for a total of 4 doses. Filgrastim (granulocyte
colony stimulating factor; G-CSF) is administered subcutaneously on days 3-10 of each cycle
of doxorubicin. At least 14 days after the last dose of doxorubicin, during week 17,
patients receive the combination of paclitaxel IV (3 hour infusion) and cisplatin, at 2 week
intervals (weeks 17, 19, 21, and 23) for a total of 4 doses. G-CSF is again administered on
days 3-10 of each of these cycles. Patients are followed every 3 months for the first 2
years, every 6 months for the next 3 years, then annually until death.
PROJECTED ACCRUAL: This study will accrue 25-30 patients in 1.5-2 years.
Primary Purpose: Treatment
Dean F. Bajorin, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|