Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Advanced Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Recurrent Urothelial Carcinoma, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Stage IV Bladder Urothelial Carcinoma AJCC v7, Unresectable Urothelial Carcinoma

In brief

This phase I/II trial studies the effect of eribulin mesylate and to see how well it works in treating patients with cancer of the urothelium that has spread to nearby tissue (locally advanced) or to other places in the body (metastatic)and kidney dysfunction. Drugs used in chemotherapy, such as 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. Chemotherapy drugs may have different effects in patients who have changes in their kidney function.

Key facts

Study ID

NCT00365157

Run by

National Cancer Institute (NCI)

People needed

132

Starts

2006-10-23

Expected to finish

2026-07-09

Last updated by the study team

2025-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have locally advanced or metastatic urothelial cancer that is not amenable to surgical treatment
• Patients must have histologically or cytologically confirmed urothelial tract carcinoma
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan
• All patients may have received up to two prior lines of chemotherapy for recurrent/advanced disease
• Patients must have received at least one platinum-based chemotherapy for recurrent/advanced disease; recurrent disease is defined as having recurred after definitive therapy and advanced disease is defined as T4 and/or N2 and/or M1; in addition, for completion of Cohort #2, patients must also have received a tubulin inhibitor as part of their therapy for urothelial cancer; for purposes of this evaluation, treatment with chemotherapy regimens where carboplatin or similar is substituted for cisplatin or where a taxane is added or removed will be considered the same regimen; tubulin inhibitors in common use include paclitaxel, docetaxel, and vinblastine; the exception to this requirement applies to women
• Women with and without prior therapy are also eligible; priority will be given to those who consent to participating in the pharmacokinetic studies
• Life expectancy of greater than 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and Karnofsky >= 60%
• Absolute neutrophil count >= 1,000/mcL
• Platelets >= 100,000/mcL
• Hemoglobin >= 9 g/dL
• Total bilirubin =< 1.5 institutional upper limit of normal (IULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X IULN
• Patients must have either (a) normal kidney function (i.e. creatinine =< 1.5 X upper limit of normal [ULN] OR calculated creatinine clearance >= 60 mL/min by the modified Cockcroft and Gault Formula OR a creatinine clearance >= 60 mL/min obtained from a 24-hour urine collection) or (b) moderate or severe renal dysfunction (i.e. creatinine clearance < 60 mL/min and >= 20 mL/min)
• Patients with symptomatic uremia, uncontrolled edema or unstable serum electrolytes should not enter the trial until such time as they have been stabilized - such patients should be discussed with the principal investigator
• Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of E7389 Halichondrin analog will be determined following review of their case by the principal investigator
• The effects of E7389 Halichondrin analog on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because tubulin inhibitors are known to be teratogenic, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Patients must have the ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

• Patients may not be receiving any other investigational agents
• Patients with brain metastasis that are unstable (i.e. presenting with neurologic symptoms that progress or require increasing doses of steroids within a 4-week period) or are untreated (i.e. not radiated) should be excluded
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study because E7389 Halichondrin analog is tubulin inhibitor agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7389 Halichondrin analog, breastfeeding should be discontinued if the mother is treated with E7389
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with E7389 Halichondrin analog; HIV-positive patients with CD4+ =< 500/mm3 are ineligible because they are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in this group of patients when indicated
• Prior therapy with E7389 Halichondrin analog (eribulin)

Where it is running

• Tower Cancer Research Foundation — Beverly Hills, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• City of Hope Antelope Valley — Lancaster, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• Veterans Administration Hospital - Martinez — Martinez, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• City of Hope South Pasadena — South Pasadena, California, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Duly Health and Care Joliet — Joliet, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Illinois CancerCare-Peoria — Peoria, Illinois, United States
• Central Illinois Hematology Oncology Center — Springfield, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Fort Wayne Medical Oncology and Hematology Inc-Parkview — Fort Wayne, Indiana, United States
• Community Howard Regional Health — Kokomo, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
• Oncology Care Associates PLLC — Saint Joseph, Michigan, United States
• Mercy Hospital Saint Louis — St Louis, Missouri, United States
• University of Pittsburgh Cancer Institute (UPCI) — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.