Stage III Bladder Cancer Clinical Trial
Official title:
Phase II Trial of Neoadjuvant Dose Dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer
The purpose of this research study is to find out what effects, good and/or bad, dose-dense (every 14 days) chemotherapy with gemcitabine (gemcitabine hydrochloride) and cisplatin given before surgery have on patients and their muscle invasive bladder cancer.
PRIMARY OBJECTIVES:
I. To assess the rate of complete response (pT0) at cystectomy following preoperative dose
dense gemcitabine and cisplatin (DD GC) in patients with muscle invasive urothelial carcinoma
of the bladder.
SECONDARY OBJECTIVES:
I. To assess the toxicity profile of DD GC when given in the neoadjuvant setting: To define
the number of patients who complete all three cycles of treatment without dose reduction, and
to describe the incidence of toxicity.
II. To assess the 5 year overall and relapse free survival in patients who receive
neoadjuvant DD GC.
TERTIARY OBJECTIVES:
I. To evaluate tissue specimens from patients to assess for molecular markers that correlate
with clinical outcome.
OUTLINE:
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on day 1 and
cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3
courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks
after chemotherapy, patients undergo radical cystectomy.
After completion of study treatment, patients are followed up for 5 years.
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