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NCT04579224

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

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-28

Study Completion Date

2030-08-15

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVE:

I. To compare overall survival in participants with metastatic urothelial carcinoma (mUC) who are randomized to standard treatment versus eribulin plus gemcitabine hydrochloride (gemcitabine).

SECONDARY OBJECTIVES:

I. To compare progression-free survival (PFS) in the standard treatment arm to the experimental treatment arm in this population.

II. To compare Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 overall response rate (ORR), both confirmed and unconfirmed, complete and partial responses (CR and PR), in the standard treatment arm to the experimental treatment arm in the subset of participants with measurable disease in this population.

III. To compare duration of response (DOR) in the standard treatment arm to the experimental treatment arm in the subset of participants with measurable disease in this population.

IV. To compare disease control rate (DCR) in the standard treatment arm to the experimental treatment arm in the subset of participants with measurable disease in this population.

BANKING OBJECTIVE:

I. To bank specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive 1 of the 4 standard of care chemotherapy regimens based on treating investigator's choice: Choice A: Patients receive docetaxel intravenously (IV) on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Choice B: Patients receive gemcitabine IV on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Choice C: Patients receive paclitaxel IV on days 1, 8, and 15 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Choice D: Patients receive sacituzumab govitecan IV on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. (EFFECTIVE NOVEMBER 18, 2024: sacituzumab govitecan is no longer included in Arm 1 for newly enrolled patients).

ARM II: Patients receive eribulin IV over 2-5 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL)

ARM III: Patients receive eribulin IV over 2-5 minutes and gemcitabine IV on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

All patients undergo computed tomography (CT), magnetic resonance imaging (MRI) throughout the trial and may undergo bone scan at the discretion of the treating physician. Patients also undergo blood and urine sample collection on the trial.

After completion of study treatment, patients are followed up every 6 months for 2 years from the date of registration, then every 12 months until death or 3 years from the date of registration

Conditions

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Metastatic Bladder Urothelial Carcinoma Metastatic Urothelial Carcinoma Refractory Bladder Urothelial Carcinoma Refractory Urothelial Carcinoma Stage IV Bladder Cancer AJCC v8

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type PROCEDURE

Undergo MRI

Paclitaxel

Intervention Type DRUG

Given IV

Sacituzumab Govitecan

Intervention Type BIOLOGICAL

Receive IV

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Biological Sample Collection Biospecimen Collected Specimen Collection Bone Scintigraphy CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan Diagnostic CAT Scan Diagnostic CAT Scan Service Type tomography Docecad RP 56976 RP-56976 RP56976 Taxotere Taxotere Injection Concentrate B1939 Mesylate E7389 ER-086526 Mesylate Halaven Halichondrin B Analog dFdCyd Difluorodeoxycytidine Hydrochloride Gemcitabine HCI Gemzar LY 188011 LY-188011 LY188011 Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat hRS7-SN38 Antibody Drug Conjugate IMMU 132 IMMU-132 IMMU132 RS7 SN38 RS7-SN38 RS7SN38 Sacituzumab Govitecan-hziy Trodelvy

Eligibility Criteria

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Inclusion Criteria

* 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
* Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarmad Sadeghi

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Identifier Type: REGISTRY

Identifier Source: secondary_id

S1937

Identifier Type: OTHER

Identifier Source: secondary_id

S1937

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180888

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2020-07651

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Arm II (eribulin)

Biospecimen Collection

Bone Scan

Computed Tomography

Eribulin Mesylate

Magnetic Resonance Imaging

Arm III (eribulin, gemcitabine)

Biospecimen Collection

Bone Scan

Computed Tomography

Eribulin Mesylate

Gemcitabine Hydrochloride

Magnetic Resonance Imaging

Arm I (standard of care chemotherapy)

Biospecimen Collection

Bone Scan

Computed Tomography

Docetaxel

Gemcitabine Hydrochloride

Magnetic Resonance Imaging

Paclitaxel

Sacituzumab Govitecan

Interventions

Biospecimen Collection

Bone Scan

Computed Tomography

Docetaxel

Eribulin Mesylate

Gemcitabine Hydrochloride

Magnetic Resonance Imaging

Paclitaxel

Sacituzumab Govitecan

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Sponsors

National Cancer Institute (NCI)

Responsible Party

Principal Investigators

Sarmad Sadeghi

Locations

Kingman Regional Medical Center

Cancer Center at Saint Joseph's

Mercy Hospital Fort Smith

CHI Saint Vincent Cancer Center Hot Springs

Mission Hope Medical Oncology - Arroyo Grande

PCR Oncology

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Keck Medicine of USC Koreatown

Los Angeles General Medical Center

USC / Norris Comprehensive Cancer Center

Fremont - Rideout Cancer Center

USC Norris Oncology/Hematology-Newport Beach

UC Irvine Health/Chao Family Comprehensive Cancer Center

Keck Medical Center of USC Pasadena

University of California Davis Comprehensive Cancer Center

Pacific Central Coast Health Center-San Luis Obispo

Mission Hope Medical Oncology - Santa Maria

UCHealth University of Colorado Hospital

Penrose-Saint Francis Healthcare

Rocky Mountain Cancer Centers-Penrose

UCHealth - Cherry Creek

AdventHealth Porter

CommonSpirit Cancer Center Mercy

Mercy Medical Center

Poudre Valley Hospital

Cancer Care and Hematology-Fort Collins

UCHealth Greeley Hospital

UCHealth Highlands Ranch Hospital

Saint Anthony Hospital

AdventHealth Littleton

UCHealth Lone Tree Health Center