S1937: A PHASE III RANDOMIZED TRIAL OF ERIBULIN (NSC #707389) WITH OR WITHOUT GEMCITABINE VERSUS STANDARD OF CARE (PHYSICIAN'S CHOICE) FOR TREATMENT OF METASTATIC UROTHELIAL CARCINOMA REFRACTORY TO, OR INELIGIBLE FOR, ANTI PD1/PDL1 THERAPY

Primary Objective

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.

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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.

Details
Age
Adult
Eligibility
Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Locations

Cherry Creek Medical Center
Greeley Campus
Harmony Campus
Highlands Ranch Hospital
Lone Tree Medical Center
Medical Center of the Rockies
Poudre Valley Hospital
University of Colorado Hospital

Principal Investigator
Photograph of Elizabeth Kessler

Elizabeth Kessler

Study ID

Protocol Number: 22-0927

More information available at ClinicalTrials.gov: NCT04579224

Categories

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