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ACTIVE NOT RECRUITING Phase 1

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

NCT00365157 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • OTHER Pharmacological Study
  • DRUG Eribulin Mesylate

Study Locations (20)

Illinois

  • University of Chicago Comprehensive Cancer Center — Chicago
  • Decatur Memorial Hospital — Decatur
  • NorthShore University HealthSystem-Evanston Hospital — Evanston
  • Ingalls Memorial Hospital — Harvey
  • Duly Health and Care Joliet — Joliet
  • Loyola University Medical Center — Maywood
  • Illinois CancerCare-Peoria — Peoria
  • Central Illinois Hematology Oncology Center — Springfield
  • Southern Illinois University School of Medicine — Springfield

California

  • Tower Cancer Research Foundation — Beverly Hills
  • City of Hope Comprehensive Cancer Center — Duarte
  • City of Hope Antelope Valley — Lancaster
  • USC / Norris Comprehensive Cancer Center — Los Angeles
  • Contra Costa Regional Medical Center — Martinez
  • Veterans Administration Hospital - Martinez — Martinez
  • University of California Davis Comprehensive Cancer Center — Sacramento
  • City of Hope South Pasadena — South Pasadena

Indiana

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview — Fort Wayne
  • Community Howard Regional Health — Kokomo
  • Northern Indiana Cancer Research Consortium — South Bend

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2006-10-23
Est. Completion 2026-07-09
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00365157

The ClinicalTrials.gov registry entry for NCT00365157 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 3 interventions — of which Laboratory Biomarker Analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00365157 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Illinois, California, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00365157 about?

NCT00365157 is a clinical study titled "Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction". 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 eri...

What is the current status of trial NCT00365157?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2006-10-23. Estimated completion is 2026-07-09.

What conditions does trial NCT00365157 study?

This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Unresectable Urothelial Carcinoma, Advanced Urothelial Carcinoma, Stage IV Bladder Urothelial Carcinoma AJCC v7. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00365157?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), Eribulin Mesylate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00365157?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00365157 being conducted?

This trial has 20 study locations across California, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial