Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer

Running, not enrolling · Phase 3

Conditions studied: Metastatic Bladder Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Refractory Bladder Urothelial Carcinoma, Refractory Urothelial Carcinoma, Stage IV Bladder Cancer AJCC v8

In brief

This phase III trial compares the usual chemotherapy treatment to eribulin plus gemcitabine in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as eribulin, gemcitabine, docetaxel, paclitaxel, and sacituzumab govitecan 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. This trial aims to see whether adding eribulin to standard of care chemotherapy may work better in treating patients with metastatic urothelial cancer.

Key facts

Study ID

NCT04579224

Run by

National Cancer Institute (NCI)

People needed

184

Starts

2021-06-28

Expected to finish

2030-08-15

Last updated by the study team

2026-08-04

Who can join

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

You may qualify if…

• Participant must have predominant histologically or cytologically proven urothelial carcinoma in a metastatic site
• Participant must have evidence of metastatic urothelial carcinoma based on CT or MRI within 28 days prior to registration
• Participant must have had progression of disease following prior therapy at the discretion of the treating investigator
• Participants must not require immediate central nervous system (CNS)-specific treatment, in the opinion of the treating investigator if they have active brain metastases (defined as new or progressive brain metastases) or leptomeningeal disease
• Participant must have had prior systemic therapy in metastatic setting that:
• Included enfortumab vedotin
• Included a PD1/PDL1 antibody
• NOTE: Under the discretion of the treating physician, participants who are not candidates for PD1/PDL1 antibody systemic therapy are allowed
• Any systemic therapy provided in adjuvant, neoadjuvant, or chemoradiation settings for urothelial carcinoma can be considered to be in metastatic setting, if the last day of treatment was within 12 months prior to the diagnosis of metastatic disease
• Participant must have completed any planned surgery or radiation therapy prior to registration
• Participant must not have unresolved toxicities from prior surgeries or radiation therapy > grade 1 at the time of registration
• Participant must be ≥ 18 years of age
• Participant must have Zubrod performance status 0-2
• Participant must have history and physical examination within 28 days prior to registration
• Participant must have complete blood count (CBC), complete metabolic panel including liver function tests, and lactate dehydrogenase (LDH) obtained within 28 days prior to registration
• Participant must have adequate kidney function as evidenced by measured or calculated creatinine clearance >= 20 mL/min within 28 days prior to registration
• Participant must have adequate hepatic function documented by either aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal (IULN) within 28 days prior to registration. If both AST and ALT are performed, both must be =< 3 x IULN. For participants with liver metastases, AST or ALT must be =< 5 x IULN
• Participant must be on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to registration if they are known to have human immunodeficiency virus (HIV)-infection
• Participants must have undetectable hepatitis B virus (HBV) viral load within 28 days prior to registration if participant has known chronic hepatitis B virus (HBV) infection
• Participants with a known history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load within 28 days prior to registration
• Participants may have a prior or concurrent malignancy provided the natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen per the opinion of the treating investigator
• Participants must not be planning to take strong or moderate CYP3A or CYP2C8 inhibitors or inducers if randomized to Arm 1 and standard of care (SOC) regimen chosen is paclitaxel or docetaxel. Participants receiving strong or moderate CYP3A- or CYP2C8 inducers must discontinue use at least 2 weeks prior to randomization
• Participant must not have a known history of corrected QT (QTc) prolongation
• Participants must not be pregnant or nursing due to the risk of harm to a fetus or nursing infant. Women and men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study and 6 months (females) or 3.5 months (males) after the last dose. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
• Participants must be offered the opportunity to participate in specimen banking as outlined

Where it is running

• Cancer Center at Saint Joseph's — Phoenix, Arizona, United States
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States
• CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas, United States
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California, United States
• PCR Oncology — Arroyo Grande, California, United States
• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
• Keck Medicine of USC Koreatown — Los Angeles, California, United States
• Los Angeles General Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Fremont - Rideout Cancer Center — Marysville, California, United States
• USC Norris Oncology/Hematology-Newport Beach — Newport Beach, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Keck Medical Center of USC Pasadena — Pasadena, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Pacific Central Coast Health Center-San Luis Obispo — San Luis Obispo, California, United States
• Mission Hope Medical Oncology - Santa Maria — Santa Maria, California, United States
• UCHealth University of Colorado Hospital — Aurora, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• Rocky Mountain Cancer Centers-Penrose — Colorado Springs, Colorado, United States
• UCHealth - Cherry Creek — Denver, Colorado, United States
• AdventHealth Porter — Denver, Colorado, United States
• CommonSpirit Cancer Center Mercy — Durango, Colorado, United States
• Mercy Medical Center — Durango, Colorado, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Kingman Regional Medical Center — Kingman, Arizona, United States

Full record on ClinicalTrials.gov

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