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 and cisplatin given before surgery have on you and your muscle invasive bladder cancer.
|Study Design:||Endpoint Classification: Safety/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|
- Rate of complete response at cystectomy [ Time Frame: Up to 60 months ] [ Designated as safety issue: Yes ]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.
- Treatment tolerability [ Time Frame: Up to 60 months ] [ Designated as safety issue: Yes ]Treatment tolerability as assessed by number of planned cycles given and dose intensity of cycles, (i.e. lack of treatment delay), and by grade of toxicity.
- Overall survival [ Time Frame: Up to 60 months ] [ Designated as safety issue: Yes ]Overall survival as determined by the percentage of patients alive at the end of the five year study period.
- Relapse free survival [ Time Frame: Up to 60 months ] [ Designated as safety issue: Yes ]Relapse free survival will be recorded up to 5 years of follow up. Relapse will be defined by appearance of new metastatic lesions, clinically or radiographically apparent, that appear after baseline imaging.
- Correlative endpoint [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]Correlative endpoints such as molecular markers of chemotherapy resistance will be analyzed in tissue specimens from cystectomy and TURBT specimens when available, with the goal of assessing their predictability for chemotherapy efficacy and survival. This is an exploratory analysis.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: Gemcitabine and Cisplatin + GCSF
Dose Dense Gemcitabine and Cisplatin + GCSF every 2 weeks x 3 cycles Gemcitabine 1200 mg/m2 Cisplatin 70 mg/m2 Pegfilgrastim 6 mg
Cisplatin 70 mg/m2 IV on Day 1 of each 14 day cycle. Number of Cycles: 3.Drug: Gemcitabine
Gemcitabine 1200 mg/m2 IV on Day 1 of each 14 day cycle. Number of Cycles: 3.
This is a single arm Phase II study utilizing neoadjuvant DD GC in patients with muscle invasive urothelial carcinoma of the bladder who will be undergoing cystectomy with goal of cure. Initial transurethral biopsy tissue may be obtained at an outside institution, but must be confirmed by pathologic review at a study site. Patients will undergo radiographic staging prior to initiation of chemotherapy, after completion of chemotherapy and surgery, and will continue on surveillance follow-up as guided by the NCCN guidelines following surgery for a total of 5 years from study entry or until death. Treatment with three cycles of DD GC will be administered on an inpatient or outpatient basis.
|Contact: Elizabeth Plimack, MD, MSfirstname.lastname@example.org|
|United States, Pennsylvania|
|Fox Chase Cancer Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19111|
|Principal Investigator: Elizabeth Plimack, MD, MS|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Jean Hoffman-Censits, MD 877-506-2703 email@example.com|
|Principal Investigator:||Elizabeth Plimack, MD, MS||Fox Chase Cancer Center|