Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With 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.
Distal Urethral Cancer
Proximal Urethral Cancer
Squamous Cell Carcinoma of the Bladder
Stage II Bladder Cancer
Stage III Bladder Cancer
Urethral Cancer Associated With Invasive Bladder Cancer
Drug: gemcitabine hydrochloride
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Neoadjuvant Dose Dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer|
- Pathological complete response rate following chemotherapy before surgery [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||December 2018|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (gemcitabine hydrochloride, cisplatin, surgery)
Patients receive gemcitabine hydrochloride 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.
Drug: gemcitabine hydrochloride
Other Names:Drug: cisplatin
Other Names:Procedure: therapeutic conventional surgery
Undergo radical cystectomyOther: laboratory biomarker analysis
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.
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.
I. To evaluate tissue specimens from patients to assess for molecular markers that correlate with clinical outcome.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611662
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Thomas Jefferson University, Kimmel Cancer Center|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Elizabeth Plimack||Fox Chase Cancer Center|