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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Given IV
Given IV
Undergo radical cystectomy
Correlative studies
Thomas Jefferson University, Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Pathological Complete Response Rate Following Chemotherapy Before Surgery
Pathological response rate following neoadjuvant chemotherapy was assessed by TNM staging at the time of radical cystectomy
Time frame: Up to 5 years
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