Phase I Trial of Dose-Dense Gemcitabine, Doxorubicin, Then Paclitaxel Plus Carboplatin In Patients With Transitional Cell Carcinoma of the Urothelium and Impaired Renal Function
- Determine the safety and toxicity of dose-dense carboplatin plus paclitaxel on a weekly
schedule given in sequence after gemcitabine and doxorubicin in patients with renal
impairment and metastatic or locally advanced transitional cell carcinoma of the
- Observe the outcome of this sequential systemic chemotherapy in these patients, or
following surgical resection as adjuvant therapy in patients in whom poor renal
function precludes the use of cisplatin-based chemotherapy.
OUTLINE: This is a dose escalation study of carboplatin.
Patients receive gemcitabine IV over 10 minutes and doxorubicin IV over 15 minutes for 5
doses on weeks 1, 3, 5, 7, and 9. Filgrastim (G-CSF) is given subcutaneously on days 3
through 10 of each 2-week course. On week 11, patients receive paclitaxel and carboplatin IV
over 1 hour weekly for 12 weeks.
Each cohort of 3 patients is entered on sequentially increasing doses of carboplatin. If any
patient experiences dose limiting toxicity (DLT), then 6 patients are entered at that dose
level. If 3 patients experience DLT at any dose level, the maximum tolerated dose has been
surpassed and a total of 6 patients are treated at the previous level.
Patients are evaluated at week 16 and at end of study.
PROJECTED ACCRUAL: There will be 18-30 patients accrued into this study over 9-15 months.
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|
|New York Weill Cornell Cancer Center at Cornell University||New York, New York 10021|