Stage IV Bladder Cancer Clinical Trial
Official title:
A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, With Pegfilgrastim for the Treatment of Patients With Metastatic Transitional Cell Carcinoma and Renal Insufficiency
This phase II trial is studying how well giving gemcitabine, paclitaxel, and doxorubicin together with pegfilgrastim works in treating patients with metastatic or unresectable bladder cancer or urinary tract cancer and kidney dysfunction. Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells. Chemotherapy drugs may have different effects in patients who have changes in their kidney function.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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 intravenous (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.
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