Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer
Launched by NATIONAL CANCER INSTITUTE (NCI) · Oct 7, 2020
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment for patients with metastatic urothelial cancer, which is a type of cancer that affects the bladder and other parts of the urinary system. Specifically, the trial is comparing the usual chemotherapy drugs to a combination of the standard treatment and a new drug called eribulin. The goal is to find out if adding eribulin to the standard chemotherapy improves outcomes for patients whose cancer has spread to other areas of the body.
To join this trial, participants should be at least 18 years old and have a confirmed diagnosis of metastatic urothelial cancer that has not responded to previous treatments. Patients should also have had certain types of prior therapies and be in stable health without serious unresolved side effects from past treatments. Those who qualify will receive either the standard chemotherapy or the new combination treatment and will be monitored throughout the study to see how well the treatments work and what side effects may occur. It's important for potential participants to discuss this option with their healthcare provider to understand if this trial is a good fit for them.
Gender
ALL
Eligibility criteria
- 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
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
New Haven, Connecticut, United States
Cleveland, Ohio, United States
Charleston, South Carolina, United States
Buffalo, New York, United States
Flint, Michigan, United States
Denver, Colorado, United States
Flint, Michigan, United States
Kalamazoo, Michigan, United States
Burnsville, Minnesota, United States
Edina, Minnesota, United States
Waconia, Minnesota, United States
Maywood, Illinois, United States
Peoria, Illinois, United States
Detroit, Michigan, United States
Oklahoma City, Oklahoma, United States
Des Moines, Iowa, United States
Great Falls, Montana, United States
Saint Paul, Minnesota, United States
Ann Arbor, Michigan, United States
Kalamazoo, Michigan, United States
Traverse City, Michigan, United States
Jackson, Mississippi, United States
Bozeman, Montana, United States
Kalispell, Montana, United States
Sheridan, Wyoming, United States
Cincinnati, Ohio, United States
Las Vegas, Nevada, United States
Dallas, Texas, United States
Las Vegas, Nevada, United States
Fort Collins, Colorado, United States
Mount Vernon, Illinois, United States
Salina, Kansas, United States
Yakima, Washington, United States
Coon Rapids, Minnesota, United States
Renton, Washington, United States
Urbana, Illinois, United States
Carroll, Iowa, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Shakopee, Minnesota, United States
Willmar, Minnesota, United States
Council Bluffs, Iowa, United States
Dayton, Ohio, United States
Effingham, Illinois, United States
Lawrence, Kansas, United States
Saint Joseph, Missouri, United States
Greenville, Ohio, United States
Bethlehem, Pennsylvania, United States
Longmont, Colorado, United States
Springfield, Illinois, United States
Houston, Texas, United States
Cincinnati, Ohio, United States
Springfield, Illinois, United States
Minneapolis, Minnesota, United States
Salt Lake City, Utah, United States
Los Angeles, California, United States
Orange, California, United States
Sacramento, California, United States
Aurora, Colorado, United States
Columbia, Missouri, United States
Saint Louis, Missouri, United States
Kearney, Nebraska, United States
Bismarck, North Dakota, United States
Fargo, North Dakota, United States
Pittsburgh, Pennsylvania, United States
Kingsport, Tennessee, United States
Aurora, Illinois, United States
Lexington, Kentucky, United States
Kettering, Ohio, United States
Allentown, Pennsylvania, United States
Federal Way, Washington, United States
Lakewood, Washington, United States
Wyoming, Michigan, United States
Cape Girardeau, Missouri, United States
Aventura, Florida, United States
Pueblo, Colorado, United States
Fridley, Minnesota, United States
Robbinsdale, Minnesota, United States
Saint Louis Park, Minnesota, United States
Saint Louis, Missouri, United States
Omaha, Nebraska, United States
Portland, Oregon, United States
Omaha, Nebraska, United States
Glens Falls, New York, United States
Fort Lauderdale, Florida, United States
Sioux Falls, South Dakota, United States
Dallas, Texas, United States
Houston, Texas, United States
Detroit, Michigan, United States
Saint Louis, Missouri, United States
Las Vegas, Nevada, United States
Green Bay, Wisconsin, United States
Marshfield, Wisconsin, United States
Reno, Nevada, United States
Miami Beach, Florida, United States
Decatur, Illinois, United States
Ottawa, Illinois, United States
Peoria, Illinois, United States
Galesburg, Illinois, United States
Cedar Rapids, Iowa, United States
Cedar Rapids, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Jackson, Michigan, United States
Lansing, Michigan, United States
Warren, Michigan, United States
Lincoln, Nebraska, United States
Papillion, Nebraska, United States
Omaha, Nebraska, United States
Cape Girardeau, Missouri, United States
Peru, Illinois, United States
Des Moines, Iowa, United States
Pontiac, Michigan, United States
Maplewood, Minnesota, United States
Maplewood, Minnesota, United States
Stillwater, Minnesota, United States
Great Falls, Montana, United States
Findlay, Ohio, United States
Seneca, Pennsylvania, United States
Bremerton, Washington, United States
Hartford, Connecticut, United States
Alton, Illinois, United States
Galesburg, Illinois, United States
Richmond, Indiana, United States
Ames, Iowa, United States
Kansas City, Kansas, United States
Topeka, Kansas, United States
Battle Creek, Michigan, United States
Grand Rapids, Michigan, United States
Saginaw, Michigan, United States
Bemidji, Minnesota, United States
Woodbury, Minnesota, United States
Joplin, Missouri, United States
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Springfield, Missouri, United States
Springfield, Missouri, United States
Billings, Montana, United States
Missoula, Montana, United States
Reno, Nevada, United States
Boardman, Ohio, United States
Dayton, Ohio, United States
Franklin, Ohio, United States
Mentor, Ohio, United States
Troy, Ohio, United States
Warren, Ohio, United States
Wright Patterson Air Force Base, Ohio, United States
Youngstown, Ohio, United States
East Stroudsburg, Pennsylvania, United States
Sioux Falls, South Dakota, United States
Green Bay, Wisconsin, United States
Minocqua, Wisconsin, United States
Oconto Falls, Wisconsin, United States
Rice Lake, Wisconsin, United States
Weston, Wisconsin, United States
Kettering, Ohio, United States
Colorado Springs, Colorado, United States
Lakewood, Colorado, United States
Springfield, Ohio, United States
Huntington, West Virginia, United States
Livonia, Michigan, United States
Bremerton, Washington, United States
Littleton, Colorado, United States
New Ulm, Minnesota, United States
Albuquerque, New Mexico, United States
Marysville, California, United States
Norton, Virginia, United States
Las Vegas, Nevada, United States
Louisville, Kentucky, United States
Torrington, Connecticut, United States
Goldsboro, North Carolina, United States
Houston, Texas, United States
Canton, Illinois, United States
Carthage, Illinois, United States
Eureka, Illinois, United States
Kewanee, Illinois, United States
Macomb, Illinois, United States
Peru, Illinois, United States
Princeton, Illinois, United States
Boise, Idaho, United States
Parker, Colorado, United States
Warrenville, Illinois, United States
Joplin, Missouri, United States
Grand Island, Nebraska, United States
Fort Smith, Arkansas, United States
Post Falls, Idaho, United States
Bloomington, Illinois, United States
Geneva, Illinois, United States
Pekin, Illinois, United States
Hays, Kansas, United States
Bolivar, Missouri, United States
Saint Louis, Missouri, United States
Erie, Pennsylvania, United States
Harrisburg, Pennsylvania, United States
Poulsbo, Washington, United States
Los Angeles, California, United States
Hot Springs, Arkansas, United States
Arroyo Grande, California, United States
Olathe, Kansas, United States
Jefferson City, Missouri, United States
Omaha, Nebraska, United States
Oklahoma City, Oklahoma, United States
Bryan, Texas, United States
Dearborn, Michigan, United States
West Des Moines, Iowa, United States
Overland Park, Kansas, United States
Kansas City, Missouri, United States
Lee's Summit, Missouri, United States
Rolla, Missouri, United States
Rolla, Missouri, United States
Fargo, North Dakota, United States
Beachwood, Ohio, United States
Bellevue, Washington, United States
Burien, Washington, United States
New Richmond, Wisconsin, United States
Springfield, Illinois, United States
Longmont, Colorado, United States
Las Vegas, Nevada, United States
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Greensburg, Pennsylvania, United States
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Clarkston, Michigan, United States
East China Township, Michigan, United States
Flint, Michigan, United States
Flint, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Livonia, Michigan, United States
Macomb, Michigan, United States
Macomb, Michigan, United States
Marlette, Michigan, United States
Pontiac, Michigan, United States
Pontiac, Michigan, United States
Pontiac, Michigan, United States
Saginaw, Michigan, United States
Sterling Heights, Michigan, United States
Warren, Michigan, United States
Warren, Michigan, United States
Warren, Michigan, United States
Warren, Michigan, United States
West Branch, Michigan, United States
Ypsilanti, Michigan, United States
Minneapolis, Minnesota, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Colorado Springs, Colorado, United States
Durango, Colorado, United States
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Bardstown, Kentucky, United States
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Louisville, Kentucky, United States
Shepherdsville, Kentucky, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Enumclaw, Washington, United States
Tacoma, Washington, United States
Carbondale, Illinois, United States
Carterville, Illinois, United States
Centralia, Illinois, United States
Danville, Illinois, United States
Decatur, Illinois, United States
Effingham, Illinois, United States
Mattoon, Illinois, United States
O'fallon, Illinois, United States
Yorkville, Illinois, United States
Louisville, Kentucky, United States
Brighton, Michigan, United States
Brownstown, Michigan, United States
Canton, Michigan, United States
Chelsea, Michigan, United States
Clinton Township, Michigan, United States
Novi, Michigan, United States
West Bloomfield, Michigan, United States
Ypsilanti, Michigan, United States
Maple Grove, Minnesota, United States
Wyoming, Minnesota, United States
Sainte Genevieve, Missouri, United States
Sullivan, Missouri, United States
Sunset Hills, Missouri, United States
Centerville, Ohio, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Findlay, Ohio, United States
Findlay, Ohio, United States
Franklin, Ohio, United States
Greenville, Ohio, United States
Troy, Ohio, United States
Bristol, Tennessee, United States
Kingsport, Tennessee, United States
Bristol, Virginia, United States
Sturgeon Bay, Wisconsin, United States
Ames, Iowa, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Baton Rouge, Louisiana, United States
Monticello, Minnesota, United States
Carson City, Nevada, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Eau Claire, Wisconsin, United States
London, Kentucky, United States
Trumbull, Connecticut, United States
Des Moines, Iowa, United States
Overland Park, Kansas, United States
Westwood, Kansas, United States
Pasadena, California, United States
North Kansas City, Missouri, United States
Phoenix, Arizona, United States
San Luis Obispo, California, United States
Santa Maria, California, United States
Tawas City, Michigan, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Fort Worth, Texas, United States
Derby, Connecticut, United States
Fairfield, Connecticut, United States
North Haven, Connecticut, United States
Waterbury, Connecticut, United States
Waterford, Connecticut, United States
Dekalb, Illinois, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Pahrump, Nevada, United States
Beavercreek, Ohio, United States
Stevens Point, Wisconsin, United States
Arroyo Grande, California, United States
Greenwich, Connecticut, United States
Hazleton, Pennsylvania, United States
Germantown, Tennessee, United States
Ballwin, Missouri, United States
Washington, Missouri, United States
Newport Beach, California, United States
Fort Dodge, Iowa, United States
Worthington, Minnesota, United States
Lake Forest, Illinois, United States
Brighton, Michigan, United States
Mechanicsburg, Pennsylvania, United States
Springfield, Ohio, United States
Fargo, North Dakota, United States
Kingman, Arizona, United States
Dixon, Illinois, United States
Washington, Illinois, United States
Farmington, Missouri, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Fort Collins, Colorado, United States
Greeley, Colorado, United States
Burnsville, Minnesota, United States
Bozeman, Montana, United States
Shelby, Michigan, United States
Cambridge, Minnesota, United States
Princeton, Minnesota, United States
Stamford, Connecticut, United States
Kalamazoo, Michigan, United States
Thief River Falls, Minnesota, United States
Monroeville, Pennsylvania, United States
Washington, Pennsylvania, United States
Richardson, Texas, United States
Glastonbury, Connecticut, United States
Melrose Park, Illinois, United States
Westerly, Rhode Island, United States
Highlands Ranch, Colorado, United States
Missoula, Montana, United States
Lone Tree, Colorado, United States
Fargo, North Dakota, United States
Fargo, North Dakota, United States
Alton, Illinois, United States
Springfield, Illinois, United States
Grand Island, Nebraska, United States
Denver, Colorado, United States
Aurora, Colorado, United States
Sheboygan, Wisconsin, United States
Kansas City, Missouri, United States
Avon, Ohio, United States
Des Moines, Iowa, United States
Kalispell, Montana, United States
Los Angeles, California, United States
Dallas, Texas, United States
Wyoming, Michigan, United States
Troy, Ohio, United States
Nampa, Idaho, United States
Pontiac, Michigan, United States
Ann Arbor, Michigan, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Danville, Illinois, United States
Guilford, Connecticut, United States
Boone, Iowa, United States
Fort Dodge, Iowa, United States
Jefferson, Iowa, United States
Marshalltown, Iowa, United States
Los Angeles, California, United States
Ames, Iowa, United States
Canton, Michigan, United States
Minocqua, Wisconsin, United States
Columbia, Missouri, United States
Ankeny, Iowa, United States
Sunset Hills, Missouri, United States
Niles, Michigan, United States
Des Moines, Iowa, United States
Clive, Iowa, United States
Lansing, Michigan, United States
Grand Rapids, Michigan, United States
Rockford, Illinois, United States
Hays, Kansas, United States
Escanaba, Michigan, United States
Jefferson City, Missouri, United States
Pontiac, Michigan, United States
Silverdale, Washington, United States
Dayton, Ohio, United States
Royal Oak, Michigan, United States
Sandpoint, Idaho, United States
Baker City, Oregon, United States
Ontario, Oregon, United States
Irvine, California, United States
Troy, Michigan, United States
Saginaw, Michigan, United States
Tawas City, Michigan, United States
Detroit, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Flint, Michigan, United States
Warren, Michigan, United States
Norton, Virginia, United States
Bristol, Virginia, United States
East China Township, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Olathe, Kansas, United States
Grosse Pointe Woods, Michigan, United States
Mount Vernon, Illinois, United States
Ankeny, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Denver, Colorado, United States
Waukee, Iowa, United States
Rolla, Missouri, United States
Littleton, Colorado, United States
Parker, Colorado, United States
Cape Girardeau, Missouri, United States
Ballwin, Missouri, United States
Patients applied
Trial Officials
Sarmad Sadeghi
Principal Investigator
SWOG Cancer Research Network
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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