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

Metastatic Urothelial Carcinoma Clinical Trial

Official title: A Phase III Randomized Trial of Eribulin (NSC #707389) With Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy

Status Recruiting

Clinical Trial Summary

This phase III trial compares the usual chemotherapy treatment to eribulin plus gemcitabine in treating patients with urothelial cancer that has spread 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.

Clinical Trial Description

PRIMARY OBJECTIVES:

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. 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. 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. 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. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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

All patients undergo computed tomography (CT), magnetic resonance imaging (MRI) and bone scan throughout the trial. 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 ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Metastatic Bladder Urothelial Carcinoma
• Metastatic Renal Pelvis Urothelial Carcinoma
• Metastatic Ureter Urothelial Carcinoma
• Metastatic Urethral Urothelial Carcinoma
• Metastatic Urothelial Carcinoma
• Pelvic Neoplasms
• Refractory Bladder Urothelial Carcinoma
• Refractory Renal Pelvis Urothelial Carcinoma
• Refractory Ureter Urothelial Carcinoma
• Refractory Urethral Urothelial Carcinoma
• Refractory Urothelial Carcinoma
• Stage IV Bladder Cancer AJCC v8
• Stage IV Renal Pelvis and Ureter Cancer AJCC v8
• Stage IV Renal Pelvis Cancer AJCC v8
• Stage IV Ureter Cancer AJCC v8
• Stage IV Urethral Cancer AJCC v8
• Stage IVA Bladder Cancer AJCC v8
• Stage IVB Bladder Cancer AJCC v8
• Ureteral Neoplasms
• Urethral Neoplasms
• Urinary Bladder Neoplasms

• NCT number: NCT04579224
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Recruiting
• Phase: Phase 3
• Start date: June 28, 2021
• Completion date: August 15, 2027