Spots Global Cancer Trial Database for Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery
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Trial Identification
Brief Title: Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery
Official Title: Phase II Trial of Gemcitabine-Eribulin (GE) in Cisplatin Ineligible Patients With Advanced or Unresectable Urothelial Carcinoma of the Bladder
Study ID: NCT02178241
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Los Angeles County-USC Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Keck Medical Center of USC Pasadena, Pasadena, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Moffitt Cancer Center P2C, Tampa, Florida, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, United States
Mayo Clinic Cancer Center P2C, Rochester, Minnesota, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Case Western Reserve University, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
University of Texas M D Anderson Cancer Center P2C, Houston, Texas, United States
University Health Network Princess Margaret Cancer Center P2C, Toronto, Ontario, Canada
Contact Details
Name: Sarmad Sadeghi
Affiliation: City of Hope Comprehensive Cancer Center LAO
Role: PRINCIPAL_INVESTIGATOR
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