A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, With Pegfilgrastim for the Treatment of Patients With Metastatic Transitional Cell Carcinoma and Renal Insufficiency
I. Assess the efficacy of gemcitabine hydrochloride, paclitaxel, doxorubicin hydrochloride,
and pegfilgrastim, in terms of response rate, in patients with metastatic or unresectable
transitional cell carcinoma of the bladder or urinary tract and renal insufficiency.
I. Assess the safety and tolerability of this regimen in these patients. II. Determine the
median time to progression in patients treated with this regimen.
III. Determine the median survival duration in patients treated with this regimen.
IV. Assess the safety and efficacy of pegfilgrastim in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin hydrochloride IV over 20 minutes, paclitaxel IV over 60
minutes, gemcitabine hydrochloride IV over 90 minutes, and pegfilgrastim subcutaneously on
day 1. Treatment repeats every 14 days for up to 9 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 3 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (complete and partial response)
The expected objective response rate with standard therapy for these patients is 0.25. We will estimate the objective response rate with a 95% confidence interval.
M.D. Anderson Cancer Center
United States: Institutional Review Board
|M D Anderson Cancer Center||Houston, Texas 77030|