NCT01611662

Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer

Phase II Trial of Neoadjuvant Dose Dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride	Given IV
DRUG	cisplatin	Given IV
PROCEDURE	therapeutic conventional surgery	Undergo radical cystectomy
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2012-05-29
• Primary completion: 2013-07-12
• Completion: 2019-01-22
• First posted: 2012-06-05
• Last updated: 2019-07-29
• Results posted: 2017-04-06

Locations

2 sites across 1 country: United States