Spots Global Cancer Trial Database for Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
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Trial Identification
Brief Title: Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Official Title: A Phase II Trial of E7389 (Halichondrin B Analog), in Patients With Metastatic Hormone Refractory Prostate Cancer
Study ID: NCT00337077
Interventions
Study Description
Brief Summary: This phase II trial is studying how well eribulin mesylate (E7389; Halichondrin B Analog) works in treating patients with metastatic prostate cancer that did not respond to hormone therapy. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Detailed Description: PRIMARY OBJECTIVES: I. Determine the number of patients with a \> 50% decrease in prostate-specific antigen (PSA) of at least 4 weeks duration in patients with hormone-refractory metastatic prostate cancer treated with E7389 (eribulin mesylate). SECONDARY OBJECTIVES: I. Estimate the measurable disease response in patients with measurable disease. II. Determine the duration of PSA and measurable disease response. III. Characterize the safety and tolerability of E7389 in these patients. OUTLINE: This study enrolled 3 cohorts of patients based on the number of prior chemotherapy regimens received. The 3 cohorts are chemonaive stratum, prior-taxane stratum, and two-prior-chemotherapy stratum. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 5 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
Community Hospital of Monterey Peninsula, Monterey, California, United States
Manchester Memorial Hospital, Manchester, Connecticut, United States
Boca Raton Regional Hospital, Boca Raton, Florida, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Rush - Copley Medical Center, Aurora, Illinois, United States
Saint Joseph Medical Center, Bloomington, Illinois, United States
Graham Hospital Association, Canton, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
Mercy Hospital and Medical Center, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Sherman Hospital, Elgin, Illinois, United States
Eureka Hospital, Eureka, Illinois, United States
Evanston CCOP-NorthShore University HealthSystem, Evanston, Illinois, United States
Galesburg Cottage Hospital, Galesburg, Illinois, United States
Illinois CancerCare Galesburg, Galesburg, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Hopedale Medical Complex - Hospital, Hopedale, Illinois, United States
Joliet Oncology-Hematology Associates Limited, Joliet, Illinois, United States
Kewanee Hospital, Kewanee, Illinois, United States
Mcdonough District Hospital, Macomb, Illinois, United States
Garneau, Stewart C MD (UIA Investigator), Moline, Illinois, United States
Porubcin, Michael MD (UIA Investigator), Moline, Illinois, United States
Sharis, Christine M MD (UIA Investigator), Moline, Illinois, United States
Stoffel, Thomas J MD (UIA Investigator), Moline, Illinois, United States
Vigliotti, Antonio, P.G. M.D. (UIA Investigator), Moline, Illinois, United States
Bromenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center Foundation, Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center, Ottawa, Illinois, United States
Pekin Cancer Treatment Center, Pekin, Illinois, United States
Pekin Hospital, Pekin, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Illinois Oncology Research Association CCOP, Peoria, Illinois, United States
OSF Saint Francis Medical Center, Peoria, Illinois, United States
Illinois Valley Hospital, Peru, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
Edward H Kaplan MD and Associates, Skokie, Illinois, United States
Saint Margaret's Hospital, Spring Valley, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Carle Clinic-Urbana Main, Urbana, Illinois, United States
Carle Foundation - Carle Cancer Center, Urbana, Illinois, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Community Howard Regional Health, Kokomo, Indiana, United States
Indiana University Health La Porte Hospital, La Porte, Indiana, United States
Saint Anthony Memorial Health Center, Michigan City, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
McFarland Clinic, Ames, Iowa, United States
Constantinou, Costas L MD (UIA Investigator), Bettendorf, Iowa, United States
Cedar Rapids Oncology Association, Cedar Rapids, Iowa, United States
Mercy Hospital, Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center, Cedar Rapids, Iowa, United States
Mercy Capitol, Des Moines, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Iowa Oncology Research Association CCOP, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
Iowa Lutheran Hospital, Des Moines, Iowa, United States
Siouxland Hematology Oncology Associates, Sioux City, Iowa, United States
Mercy Medical Center-Sioux City, Sioux City, Iowa, United States
Saint Luke's Regional Medical Center, Sioux City, Iowa, United States
Eastern Cooperative Oncology Group, Boston, Massachusetts, United States
Bixby Medical Center, Adrian, Michigan, United States
Hickman Cancer Center, Adrian, Michigan, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium Community Clinical Oncology Program, Ann Arbor, Michigan, United States
Oakwood Hospital, Dearborn, Michigan, United States
Saint John Hospital and Medical Center, Detroit, Michigan, United States
Green Bay Oncology - Escanaba, Escanaba, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus, Flint, Michigan, United States
Green Bay Oncology - Iron Mountain, Iron Mountain, Michigan, United States
Allegiance Health, Jackson, Michigan, United States
Sparrow Hospital, Lansing, Michigan, United States
Saint Mary Mercy Hospital, Livonia, Michigan, United States
Community Cancer Center of Monroe, Monroe, Michigan, United States
Mercy Memorial Hospital, Monroe, Michigan, United States
Saint Joseph Mercy Oakland, Pontiac, Michigan, United States
Saint Joseph Mercy Port Huron, Port Huron, Michigan, United States
Saint Mary's of Michigan, Saginaw, Michigan, United States
Lakeland Hospital, St. Joseph, Michigan, United States
Saint John Macomb-Oakland Hospital, Warren, Michigan, United States
Sanford Clinic North-Bemidgi, Bemidji, Minnesota, United States
Essentia Health Duluth Clinic CCOP, Duluth, Minnesota, United States
Essentia Health Saint Mary's Medical Center, Duluth, Minnesota, United States
Miller-Dwan Hospital, Duluth, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
Meeker County Memorial Hospital, Litchfield, Minnesota, United States
Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
Saint Joseph's Hospital - Healtheast, Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota, United States
Woodwinds Health Campus, Woodbury, Minnesota, United States
Hunterdon Medical Center, Flemington, New Jersey, United States
Hackensack University Medical CCOP, Hackensack, New Jersey, United States
Cancer Institute of New Jersey At Hamilton, Hamilton, New Jersey, United States
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County, Mount Holly, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Virtua West Jersey Hospital Voorhees, Voorhees, New Jersey, United States
The North Division of Montefiore Medical Center, Bronx, New York, United States
New York University Langone Medical Center, New York, New York, United States
Sanford Clinic North-Fargo, Fargo, North Dakota, United States
Sanford Medical Center-Fargo, Fargo, North Dakota, United States
Toledo Clinic Cancer Centers-Bowling Green, Bowling Green, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
North Coast Cancer Care-Clyde, Clyde, Ohio, United States
Hematology Oncology Center Incorporated, Elyria, Ohio, United States
Lima Memorial Hospital, Lima, Ohio, United States
Toledo Clinic Cancer Centers-Maumee, Maumee, Ohio, United States
Saint Luke's Hospital, Maumee, Ohio, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center, Maumee, Ohio, United States
Saint Charles Hospital, Oregon, Ohio, United States
Toledo Clinic Cancer Centers-Oregon, Oregon, Ohio, United States
North Coast Cancer Care, Sandusky, Ohio, United States
Flower Hospital, Sylvania, Ohio, United States
Mercy Hospital of Tiffin, Tiffin, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital, Toledo, Ohio, United States
Saint Vincent Mercy Medical Center, Toledo, Ohio, United States
University of Toledo, Toledo, Ohio, United States
Toledo Community Hospital Oncology Program CCOP, Toledo, Ohio, United States
Mercy Cancer Center at Saint Anne Mercy Hospital, Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States
Fulton County Health Center, Wauseon, Ohio, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Saint Luke's Hospital, Bethlehem, Pennsylvania, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
Lewistown Hospital, Lewistown, Pennsylvania, United States
Mount Nittany Medical Center, State College, Pennsylvania, United States
Fredericksburg Oncology Inc, Fredericksburg, Virginia, United States
Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, United States
Saint Vincent Hospital, Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay, Wisconsin, United States
Saint Mary's Hospital, Green Bay, Wisconsin, United States
UW Health Oncology - 1 South Park, Madison, Wisconsin, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Bay Area Medical Center, Marinette, Wisconsin, United States
Green Bay Oncology - Oconto Falls, Oconto Falls, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Riverview Hospital, Wisconsin Rapids, Wisconsin, United States
Contact Details
Name: Mark Stein, M.D.
Affiliation: Rutgers Cancer Institute of New Jersey
Role: STUDY_CHAIR
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