Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer
|ClinicalTrials.gov Identifier: NCT01611662|
Recruitment Status : Terminated (Extreme Toxicity)
First Posted : June 5, 2012
Results First Posted : April 6, 2017
Last Update Posted : April 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|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 Drug: cisplatin Procedure: therapeutic conventional surgery Other: laboratory biomarker analysis||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Neoadjuvant Dose Dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer|
|Study Start Date :||May 2012|
|Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2018|
U.S. FDA Resources
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
- Pathological Complete Response Rate Following Chemotherapy Before Surgery [ Time Frame: Up to 5 years ]Pathological response rate following neoadjuvant chemotherapy was assessed by TNM staging at the time of radical cystectomy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611662
|United States, Pennsylvania|
|Thomas Jefferson University, Kimmel Cancer Center|
|Philadelphia, Pennsylvania, United States, 19107|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Principal Investigator:||Elizabeth Plimack||Fox Chase Cancer Center|