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Comparing the New Anti-cancer Drug Eribulin with or without Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer

Trial Status: Active

This phase III trial compares the usual chemotherapy treatment to eribulin alone and 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, and paclitaxel, 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.

Inclusion Criteria

  • Participant must have predominant histologically and cytologically proven urothelial carcinoma in a metastatic site
  • Participant must have evidence of metastatic urothelial carcinoma based on computed tomography (CT) or magnetic resonance imaging (MRI) within 28 days prior to registration
  • Participant must have had progression of disease following prior therapy at the discretion of the treating investigator
  • Participant must have received previous systemic treatment for metastatic urothelial carcinoma with either a platinum-based chemotherapy regimen, systemic PD1/PDL1 immunotherapy, an antibody drug conjugate such as, enfortumab vedotin or sacituzumab govitecan (through standard of care or a clinical trial). There is no limit to the number of prior regimens patient may have received for urothelial carcinoma * If participant is a candidate for a platinum-based chemotherapy, then participant must have previously received a platinum-based chemotherapy * If participant is a candidate for immunotherapy, then participant must have previously received immunotherapy. If participant is not a candidate for immunotherapy, then participant either: (a) must have had prior anti PD1/PDL1 antibody therapy; OR (b) must have not been a candidate for anti PD1/PDL1 antibody therapy in the opinion of the treating physician * Participant is eligible if platinum based chemotherapy and/or anti PDL/PDL1 antibody therapy was provided in perioperative setting before or after radical cystectomy and if there is evidence of progression to metastatic disease within 12 months of the last dose of therapy. For instance, a patient treated with dose-dense combination of methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) in neoadjuvant setting, then radical cystectomy followed by adjuvant pembrolizumab on AMBASSADOR trial will meet the requirement for prior/concurrent therapy if progression of disease occurs within 12 months of discontinuation of pembrolizumab
  • Participant must have received any planned surgery prior to registration
  • 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 with 28 days prior to registration
  • Participant must have adequate kidney function as evidenced by measured or calculated creatinine clearance >= 50 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 be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria

  • 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 not have progressed within 3 months following last dose of gemcitabine
  • Participant must not have unresolved toxicities from prior surgeries or radiation therapy > grade 1 at the time of registration to registration
  • 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

Arizona

Kingman
Kingman Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phoenix
Cancer Center at Saint Joseph's
Status: ACTIVE
Contact: Site Public Contact
Phone: 602-406-8222

Arkansas

Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

California

Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-851-2283
PCR Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
Newport Beach
USC Norris Oncology / Hematology-Newport Beach
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
Pasadena
Keck Medical Center of USC Pasadena
Status: ACTIVE
Contact: Site Public Contact
Phone: 323-865-0451
San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
Status: ACTIVE
Contact: Site Public Contact
Santa Maria
Mission Hope Medical Oncology - Santa Maria
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-851-2283

Colorado

Colorado Springs
Penrose-Saint Francis Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Rocky Mountain Cancer Centers-Penrose
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Denver
Porter Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Durango
Mercy Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Southwest Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Lakewood
Saint Anthony Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Littleton
Littleton Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Longmont
Longmont United Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Rocky Mountain Cancer Centers-Longmont
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Parker
Parker Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Pueblo
Saint Mary Corwin Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Florida

Aventura
Mount Sinai Comprehensive Cancer Center at Aventura
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-674-2625
Fort Lauderdale
Holy Cross Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 954-267-7750
Miami Beach
Mount Sinai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-674-2625

Illinois

Aurora
Rush - Copley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-978-6212
Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Carbondale
Memorial Hospital of Carbondale
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-457-5200
Carterville
SIH Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-985-3333
Carthage
Illinois CancerCare-Carthage
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Centralia
Centralia Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Dixon
Illinois CancerCare-Dixon
Status: ACTIVE
Contact: Site Public Contact
Phone: 815-285-7800
Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Eureka
Illinois CancerCare-Eureka
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Western Illinois Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-344-2831
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Macomb
Illinois CancerCare-Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Methodist Medical Center of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Valley Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-788-3528
Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-7541
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Yorkville
Rush-Copley Healthcare Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-978-6212

Iowa

Ames
Mary Greeley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
McFarland Clinic PC - Ames
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-239-4734
Boone
McFarland Clinic PC-Boone
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Mercy Cancer Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Council Bluffs
Alegent Health Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Creston
Greater Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Des Moines
Medical Oncology and Hematology Associates-Laurel
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Mercy Medical Center - Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Jefferson
McFarland Clinic PC-Jefferson
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Marshalltown
McFarland Clinic PC-Marshalltown
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
West Des Moines
Mercy Medical Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Kentucky

Bardstown
Flaget Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Corbin
Commonwealth Cancer Center-Corbin
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Lexington
Saint Joseph Hospital East
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Saint Joseph Radiation Oncology Resource Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
London
Saint Joseph London
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Louisville
Jewish Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Jewish Hospital Medical Center Northeast
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Saints Mary and Elizabeth Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Shepherdsville
Jewish Hospital Medical Center South
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Brighton
IHA Hematology Oncology Consultants-Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Canton
IHA Hematology Oncology Consultants-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Caro
Caro Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Chelsea
IHA Hematology Oncology Consultants-Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Clarkston
Hematology Oncology Consultants-Clarkston
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Newland Medical Associates-Clarkston
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Detroit
Ascension Saint John Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
East China
Great Lakes Cancer Management Specialists-Doctors Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Flint
Genesee Cancer and Blood Disease Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Genesee Hematology Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Genesys Hurley Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Hurley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Grosse Pointe Woods
Academic Hematology Oncology Specialists
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Michigan Breast Specialists-Grosse Pointe Woods
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Lansing
Sparrow Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Livonia
Hope Cancer Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Mary Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Michigan Breast Specialists-Macomb Township
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Marlette
Saint Mary's Oncology / Hematology Associates of Marlette
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Pontiac
21st Century Oncology-Pontiac
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Hope Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Newland Medical Associates-Pontiac
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Oakland
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saginaw
Ascension Saint Mary's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Oncology Hematology Associates of Saginaw Valley PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Tawas City
Ascension Saint Joseph Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Warren
Advanced Breast Care Center PLLC
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Great Lakes Cancer Management Specialists-Macomb Professional Building
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Macomb Hematology Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Michigan Breast Specialists-Warren
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint John Macomb-Oakland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
West Branch
Saint Mary's Oncology / Hematology Associates of West Branch
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Ypsilanti
Huron Gastroenterology PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
IHA Hematology Oncology Consultants-Ann Arbor
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-333-5000
Burnsville
Fairview Ridges Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Minnesota Oncology - Burnsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Cambridge
Cambridge Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Coon Rapids
Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Edina
Fairview Southdale Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Fridley
Unity Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint John's Hospital - Healtheast
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Minneapolis
Abbott-Northwestern Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Health Partners Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Hennepin County Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Monticello
Monticello Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
New Ulm
New Ulm Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Princeton
Fairview Northland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Robbinsdale
North Memorial Medical Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
United Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Shakopee
Saint Francis Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Stillwater
Lakeview Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Thief River Falls
Sanford Thief River Falls Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320
Waconia
Ridgeview Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Willmar
Rice Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Worthington
Sanford Cancer Center Worthington
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320
Wyoming
Fairview Lakes Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-651-5550
Farmington
Parkland Health Center - Farmington
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Jefferson City
Capital Region Southwest Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-632-4814
Saint Louis
Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Sullivan
Missouri Baptist Sullivan Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569

Nebraska

Grand Island
CHI Health Saint Francis
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Kearney
CHI Health Good Samaritan
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Lincoln
Saint Elizabeth Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Omaha
Alegent Health Bergan Mercy Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Alegent Health Immanuel Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Alegent Health Lakeside Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Creighton University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Papillion
Midlands Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Nevada

Carson City
Carson Tahoe Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Henderson
21st Century Oncology-Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Cancer and Blood Specialists-Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Cancer Center-Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Urology - Green Valley
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Pebble
Status: ACTIVE
Contact: Site Public Contact
OptumCare Cancer Care at Seven Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Urology Specialists of Nevada - Green Valley
Status: ACTIVE
Contact: Site Public Contact
Las Vegas
21st Century Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
21st Century Oncology-Fort Apache
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
21st Century Oncology-Vegas Tenaya
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Ann M Wierman MD LTD
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Central Valley
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Northwest
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Town Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Summerlin
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Desert West Surgery
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Hope Cancer Care of Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Cancer Center-Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Prostate Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Cathedral Rock
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Pecos
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Smoke Ranch
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Sunset
Status: ACTIVE
Contact: Site Public Contact
OptumCare Cancer Care at Charleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at Fort Apache
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at MountainView
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Central
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Southeast
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Summerlin Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Sunrise Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
University Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
University Medical Center of Southern Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Urology Specialists of Nevada - Central
Status: ACTIVE
Contact: Site Public Contact
Urology Specialists of Nevada - Northwest
Status: ACTIVE
Contact: Site Public Contact
Urology Specialists of Nevada - Southwest
Status: ACTIVE
Contact: Site Public Contact
Pahrump
Hope Cancer Care of Nevada-Pahrump
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Reno
Radiation Oncology Associates
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Renown Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Saint Mary's Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013

New York

Glens Falls
Glens Falls Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 518-926-6700

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Fargo
Sanford Broadway Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Sanford Medical Center Fargo
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-437-4010
Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161
Sanford South University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161
Southpointe-Sanford Medical Center Fargo
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Ohio

Cincinnati
Bethesda North Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Good Samaritan Hospital - Cincinnati
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
TriHealth Cancer Institute-Anderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
TriHealth Cancer Institute-Westside
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
East Stroudsburg
Pocono Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Hazleton
Lehigh Valley Hospital-Hazleton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671

South Dakota

Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Tennessee

Bristol
Wellmont Bristol Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 423-578-8538
Kingsport
Regional Cancer Center at Indian Path Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 423-578-8538
Wellmont Holston Valley Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 423-578-8538

Texas

Bryan
Saint Joseph Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Virginia

Bristol
Wellmont Medical Associates-Bristol
Status: ACTIVE
Contact: Site Public Contact
Phone: 423-578-8538
Norton
Southwest VA Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 423-578-8538

Washington

Bellevue
Overlake Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-688-5407
Bremerton
Harrison HealthPartners Hematology and Oncology-Bremerton
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Harrison Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Burien
Highline Medical Center-Main Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Enumclaw
Saint Elizabeth Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Federal Way
Saint Francis Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Lakewood
Saint Clare Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Poulsbo
Harrison HealthPartners Hematology and Oncology-Poulsbo
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Renton
Valley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-228-3440
Tacoma
Franciscan Research Center-Northwest Medical Plaza
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Wisconsin

New Richmond
Cancer Center of Western Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

PRIMARY OBJECTIVES:

I. To compare overall survival (OS) in participants with metastatic urothelial carcinoma (mUC) who are randomized to standard treatment versus eribulin mesylate (eribulin) alone.

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

III. To compare overall survival in participants with metastatic urothelial carcinoma (mUC) who are randomized to eribulin alone versus eribulin plus gemcitabine.

SECONDARY OBJECTIVES:

I. To compare progression-free survival (PFS) in the standard treatment arm to the two experimental treatment arms 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 two experimental treatment arms 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 two experimental treatment arms 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 two experimental treatment arms 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 3 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.

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.

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.

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

Trial Phase Phase III

Trial Type Treatment

Lead Organization
SWOG

Principal Investigator
Sarmad Sadeghi

  • Primary ID S1937
  • Secondary IDs NCI-2020-07651
  • Clinicaltrials.gov ID NCT04579224