Eribulin Mesylate for Advanced Bladder Cancer

Recruiting in Palo Alto (17 mi)

+26 other locations

Overseen byDavid I. Quinn

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

David I. Quinn

Principal Investigator

City of Hope Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with advanced or metastatic urothelial cancer that can't be removed by surgery. They should have had some prior chemotherapy, but not the drug being tested. Participants need to have a life expectancy over 6 months, acceptable organ function, and agree to use contraception. Those with HIV on antiretroviral therapy, unstable brain metastasis, or severe illnesses are excluded.

Inclusion Criteria

My doctor expects me to live more than 6 months.

My bladder cancer cannot be removed with surgery and has spread.

My cancer is confirmed to be urothelial carcinoma.

See 15 more

Exclusion Criteria

I am HIV-negative or if positive, not on antiretroviral therapy and have a CD4+ count > 500/mm3.

Patients may not be receiving any other investigational agents

I am not pregnant or breastfeeding if I am to be treated with E7389.

See 3 more

Treatment Details

Interventions

Eribulin Mesylate (Microtubule Inhibitor)

Trial OverviewThe trial is testing Eribulin Mesylate's effectiveness in patients with kidney dysfunction and locally advanced or metastatic urothelial cancer. It includes laboratory biomarker analysis and pharmacological studies to understand how the drug works when kidneys aren't functioning normally.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (eribulin mesylate)Experimental Treatment3 Interventions

Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Eribulin Mesylate is already approved in Canada, Japan for the following indications: