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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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