NCT02178241

Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery

Phase II Trial of Gemcitabine-Eribulin (GE) in Cisplatin Ineligible Patients With Advanced or Unresectable Urothelial Carcinoma of the Bladder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well gemcitabine hydrochloride and eribulin mesylate work in treating patients with bladder cancer that has spread to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the objective response rate of gemcitabine (gemcitabine hydrochloride)-eribulin (eribulin mesylate) (GE) when given to cisplatin ineligible patients with advanced or unresectable urothelial carcinoma who have not received any prior chemotherapy for the advanced disease. SECONDARY OBJECTIVES: I. To estimate the median progression-free survival (PFS). II. To summarize the toxicity profile (using Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 4 criteria) of the GE regimen in these patients. OUTLINE: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8 and eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 36 months.

Conditions

• Metastatic Ureter Carcinoma
• Metastatic Urethral Carcinoma
• Stage III Bladder Urothelial Carcinoma AJCC v6 and v7
• Stage III Ureter Cancer AJCC v7
• Stage III Urethral Cancer AJCC v7
• Stage IV Bladder Urothelial Carcinoma AJCC v7
• Stage IV Ureter Cancer AJCC v7
• Stage IV Urethral Cancer AJCC v7
• Ureter Urothelial Carcinoma
• Urethral Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Eribulin Mesylate	Given IV
DRUG	Gemcitabine Hydrochloride	Given IV

Timeline

• Start date: 2014-12-11
• Primary completion: 2019-03-18
• Completion: 2019-07-11
• First posted: 2014-06-30
• Last updated: 2019-12-16
• Results posted: 2019-12-16

Locations

18 sites across 2 countries: United States, Canada