Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT02178241|
Recruitment Status : Active, not recruiting
First Posted : June 30, 2014
Last Update Posted : March 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Eribulin Mesylate Drug: Gemcitabine Hydrochloride||Phase 2|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Gemcitabine-Eribulin (GE) in Cisplatin Ineligible Patients With Advanced or Unresectable Urothelial Carcinoma of the Bladder|
|Actual Study Start Date :||December 11, 2014|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Treatment (eribulin mesylate and gemcitabine hydrochloride)
Patients receive gemcitabine hydrochloride 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.
Drug: Eribulin Mesylate
Drug: Gemcitabine Hydrochloride
- Objective response rate defined as either a confirmed complete response (CR) or a confirmed partial response (PR) based on RECIST version 1.1 [ Time Frame: Up to 36 months ]
- PFS using RECIST v1.1 [ Time Frame: From the start of treatment on day 1, until progression, death, or the start of another treatment, assessed up to 12 months ]PFS will be summarized with a Kaplan-Meier plot and confidence intervals (at 3, 6, 9, and 12 months).
- Overall survival [ Time Frame: Up to 36 months ]Summarized with a Kaplan-Meier plot and confidence intervals.
- Incidence of adverse events as graded by the CTCAE v. 4 [ Time Frame: Up to 36 months ]All observed toxicities will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by the CTCAE v4.0), and time of onset (i.e. course of treatment). Tables will be created to summarize these toxicities and side effects, overall, by course - possibly by the cause of the cisplatin ineligibility, if numbers permit.
- Overall response rate (ORR) [ Time Frame: Up to 36 months ]ORR will be calculated as the ratio of the number of eligible patients who experienced a confirmed CR or PR (by RECIST v1.1) divided by the total number of eligible patients who began treatment; 90% confidence intervals will be constructed. A secondary estimate (more conservative) of the overall response rate will count in the numerator, only those patients who experienced a confirmed CR or PR AND who received 2 or more doses of eribulin mesylate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178241
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010|
|Los Angeles County-USC Medical Center|
|Los Angeles, California, United States, 90033|
|USC / Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Keck Medical Center of USC Pasadena|
|Pasadena, California, United States, 91105|
|University of California Davis Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|United States, Colorado|
|University of Colorado Hospital|
|Aurora, Colorado, United States, 80045|
|United States, District of Columbia|
|MedStar Georgetown University Hospital|
|Washington, District of Columbia, United States, 20007|
|United States, Florida|
|Moffitt Cancer Center P2C|
|Tampa, Florida, United States, 33612|
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|UC Comprehensive Cancer Center at Silver Cross|
|New Lenox, Illinois, United States, 60451|
|United States, Minnesota|
|Mayo Clinic Cancer Center P2C|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute (UPCI)|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, Texas|
|University of Texas M D Anderson Cancer Center P2C|
|Houston, Texas, United States, 77030|
|University Health Network Princess Margaret Cancer Center P2C|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Sarmad Sadeghi||City of Hope Comprehensive Cancer Center LAO|