Bladder Cancer Clinical Trial
Official title:
A Phase II Trial Of Adjuvant Chemotherapy For High Risk Transitional Cell Carcinoma Of The Urothelium
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following
surgery in treating patients who have urinary tract cancer.
OBJECTIVES:
- Determine the time to treatment failure and disease-free survival in patients with
high-risk transitional cell carcinoma of the urothelium treated with adjuvant
paclitaxel, ifosfamide, carboplatin, and gemcitabine.
- Determine the tolerability and feasibility of this regimen in these patients.
OUTLINE: Patients are stratified according to disease stage.
Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour on day 1,
ifosfamide IV over 1 hour on days 1-3, and filgrastim (G-CSF) subcutaneously (SC) once daily
beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21
days for a total of 2 courses.
Beginning 3 weeks after the completion of the second course of chemotherapy, patients
receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day
1. Patients also receive G-CSF SC once daily on days 2-6 and again beginning on day 9 and
continuing until blood counts recover. Treatment repeats every 21 days for a total of 2
courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 months, every 6 months for 2 years, and then annually for 3
years.
PROJECTED ACCRUAL: A total of 10-30 patients will be accrued for this study.
;
Primary Purpose: Treatment
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