Comparing the New Anti-Cancer Drug Eribulin with Chemotherapy to Usual Chemotherapy Alone in Metastatic Urothelial Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04579224

Provider View

This study is testing whether adding a new drug, Eribulin, to standard chemotherapy can better treat urothelial cancer that has spread to other parts of the body compared to chemotherapy alone.

Patient Parameters

Program Overview

This phase III clinical trial is exploring if a new drug, Eribulin, combined with another chemotherapy drug, Gemcitabine, is more effective than the usual chemotherapy treatments for patients with urothelial cancer that has spread (metastatic). Chemotherapy drugs work by killing cancer cells, stopping them from dividing, or preventing them from spreading. The study aims to find out if adding Eribulin to the standard chemotherapy can improve treatment outcomes for patients with metastatic urothelial cancer.

Description

The main goal of this study is to compare the overall survival of patients with metastatic urothelial cancer who receive standard chemotherapy treatment to those who receive Eribulin plus Gemcitabine.

Secondary goals include comparing how long patients live without the cancer getting worse, the response rate of the cancer to the treatment, the duration of the response, and the overall disease control rate between the two groups.

The study also involves collecting samples for future research.

Participants are randomly assigned to one of three groups:

  • Group 1: Receives one of four standard chemotherapy treatments chosen by the doctor:

    • Option A: Docetaxel given intravenously every 21 days.
    • Option B: Gemcitabine given intravenously on days 1, 8, and 15 every 28 days.
    • Option C: Paclitaxel given intravenously on days 1, 8, and 15 every 21 days.
    • Option D: Sacituzumab govitecan given intravenously on days 1 and 8 every 21 days.

  • Group 2: Receives Eribulin intravenously on days 1 and 8 every 21 days. (This group is no longer accepting new participants.)

  • Group 3: Receives Eribulin and Gemcitabine intravenously on days 1 and 8 every 21 days.

All participants will have regular CT, MRI, and bone scans, as well as blood and urine tests throughout the study. After finishing the treatment, participants will have follow-up visits every 6 months for 2 years, then annually for up to 3 years.

Eligibility Criteria

Inclusion Criteria

  • Must have urothelial cancer that has spread to other parts of the body, confirmed by lab tests.
  • Must have a CT or MRI scan showing the cancer has spread within 28 days before joining the study.
  • Must have had cancer progression after previous treatment.
  • Must not need immediate treatment for brain metastases if present.
  • Must have had previous treatments including enfortumab vedotin and a PD1/PDL1 antibody, unless not suitable for PD1/PDL1 therapy.
  • Must have completed any planned surgery or radiation before joining the study.
  • Must not have unresolved side effects from previous treatments above grade 1.
  • Must be 18 years or older.
  • Must have a performance status score of 0-2, indicating good overall health.
  • Must have recent medical exams and blood tests within 28 days before joining the study.
  • Must have adequate kidney and liver function as shown by specific blood tests.
  • If HIV positive, must be on effective treatment with undetectable viral load.
  • If hepatitis B or C positive, must have undetectable viral load.
  • Can have other cancers if they do not interfere with this study.
  • Must not be taking certain medications that interfere with the study drugs.
  • Must not have a history of heart rhythm problems.
  • Must not be pregnant or nursing and must agree to use effective birth control during and after the study.
  • Must understand the study and agree to participate by signing a consent form.

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