A Phase II Trial of E7389 (Halichondrin B Analog), in Patients With Metastatic Hormone Refractory Prostate Cancer
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:
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with a greater than or equal to 50% decrease in Prostate-specific antigen (PSA) levels
Baseline and 4 weeks
No
Mark Stein
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2009-00566
NCT00337077
November 2006
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Hurley Medical Center | Flint, Michigan 48503 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Virginia Piper Cancer Institute | Minneapolis, Minnesota 55407 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
Lewistown Hospital | Lewistown, Pennsylvania 17044 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Memorial Hospital | Carthage, Illinois 62321 |
Mercy Hospital and Medical Center | Chicago, Illinois 60616 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Kewanee Hospital | Kewanee, Illinois 61443 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Proctor Hospital | Peoria, Illinois 61614 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Community Cancer Center of Monroe | Monroe, Michigan 48162 |
Wood County Oncology Center | Bowling Green, Ohio 43402 |
Lima Memorial Hospital | Lima, Ohio 45804 |
Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
Fulton County Health Center | Wauseon, Ohio 43567 |
Eureka Hospital | Eureka, Illinois 61530 |
Graham Hospital Association | Canton, Illinois 61520 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
Pekin Hospital | Pekin, Illinois 61554 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Bixby Medical Center | Adrian, Michigan 49221 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Saint Francis Regional Medical Center | Shakopee, Minnesota 55379 |
Saint Luke's Hospital | Maumee, Ohio 43537 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
Manchester Memorial Hospital | Manchester, Connecticut 06040-4188 |
Sherman Hospital | Elgin, Illinois 60120-2198 |
Memorial Medical Center | Springfield, Illinois 62781 |
Woodwinds Health Campus | Woodbury, Minnesota 55125 |
Hennepin County Medical Center | Minneapolis, Minnesota |
Case Western Reserve University | Cleveland, Ohio 44106 |
Toledo Clinic | Oregon, Ohio 43616 |
Flower Hospital | Sylvania, Ohio 43560-2197 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Oncology Associates | Cedar Rapids, Iowa 52403 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Penn State Milton S Hershey Medical Center | Hershey, Pennsylvania 17033 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
Community Hospital of Monterey Peninsula | Monterey, California 93940 |
Rush - Copley Medical Center | Aurora, Illinois 60504 |
Evanston CCOP-NorthShore University HealthSystem | Evanston, Illinois 60201 |
Hopedale Medical Complex - Hospital | Hopedale, Illinois 61747 |
Joliet Oncology-Hematology Associates Limited | Joliet, Illinois 60435 |
Vigliotti, Antonio, P.G. M.D. (UIA Investigator) | Moline, Illinois 61265 |
Stoffel, Thomas J MD (UIA Investigator) | Moline, Illinois 61265 |
Garneau, Stewart C MD (UIA Investigator) | Moline, Illinois 61265 |
Sharis, Christine M MD (UIA Investigator) | Moline, Illinois 61265 |
Porubcin, Michael MD (UIA Investigator) | Moline, Illinois 61265 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois 61350 |
Ottawa Regional Hospital and Healthcare Center | Ottawa, Illinois 61350 |
Pekin Cancer Treatment Center | Pekin, Illinois 61554 |
Illinois Oncology Research Association CCOP | Peoria, Illinois 61615 |
Illinois CancerCare-Peoria | Peoria, Illinois 61615 |
Illinois Valley Hospital | Peru, Illinois 61354 |
Edward H Kaplan MD and Associates | Skokie, Illinois 60076 |
Saint Margaret's Hospital | Spring Valley, Illinois 61362 |
Carle Clinic-Urbana Main | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Center | Michigan City, Indiana 46360 |
Saint Joseph's Medical Center | South Bend, Indiana 46617 |
McFarland Clinic | Ames, Iowa 50010 |
Constantinou, Costas L MD (UIA Investigator) | Bettendorf, Iowa 52722 |
Cedar Rapids Oncology Association | Cedar Rapids, Iowa 52403 |
Mercy Hospital | Cedar Rapids, Iowa 52403 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Capitol | Des Moines, Iowa 50307 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Siouxland Hematology - Oncology Associates | Sioux City, Iowa 51101 |
Hickman Cancer Center | Adrian, Michigan 49221 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Green Bay Oncology - Escanaba | Escanaba, Michigan 49431 |
Green Bay Oncology - Iron Mountain | Iron Mountain, Michigan 49801 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Memorial Hospital | Monroe, Michigan 48162 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Lakeland Hospital | St. Joseph, Michigan 49085 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Saint Mary's Medical Center | Duluth, Minnesota 55805 |
Miller-Dwan Hospital | Duluth, Minnesota 55805 |
Saint John's Hospital - Healtheast | Maplewood, Minnesota 55109 |
Saint Joseph's Hospital - Healtheast | Saint Paul, Minnesota 55102 |
Hunterdon Medical Center | Flemington, New Jersey 08822 |
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County | Mount Holly, New Jersey 08060 |
Virtua West Jersey Hospital Voorhees | Voorhees, New Jersey 08043 |
The North Division of Montefiore Medical Center | Bronx, New York 10466 |
New York University Langone Medical Center | New York, New York 10016 |
Hematology Oncology Center Incorporated | Elyria, Ohio 44035 |
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center | Maumee, Ohio 43537 |
Saint Charles Hospital | Oregon, Ohio 43616 |
North Coast Cancer Care | Sandusky, Ohio 44870 |
Toledo Community Hospital Oncology Program CCOP | Toledo, Ohio 43617 |
Mercy Cancer Center at Saint Anne Mercy Hospital | Toledo, Ohio 43623 |
University of Toledo | Toledo, Ohio 43614 |
The Toledo Hospital | Toledo, Ohio 43606 |
Saint Vincent Mercy Medical Center | Toledo, Ohio 43608 |
Saint Luke's Hospital | Bethlehem, Pennsylvania 18015 |
Fredericksburg Oncology Inc | Fredericksburg, Virginia 22401 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Green Bay Oncology at Saint Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
UW Health Oncology - 1 South Park | Madison, Wisconsin 53715 |
Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Hackensack University Medical CCOP | Hackensack, New Jersey 07601 |
North Coast Cancer Care-Clyde | Clyde, Ohio 43410 |
Riverview Hospital | Wisconsin Rapids, Wisconsin 54494 |
Boca Raton Regional Hospital | Boca Raton, Florida 33486 |
Carle Foundation - Carle Cancer Center | Urbana, Illinois 61801 |
Sanford Clinic North-Fargo | Fargo, North Dakota 58102 |
Sanford Medical Center-Fargo | Fargo, North Dakota 58122 |
Eastern Cooperative Oncology Group | Boston, Massachusetts 02215 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Sanford Clinic North-Bemidgi | Bemidji, Minnesota 56601 |
Essentia Health Duluth Clinic CCOP | Duluth, Minnesota 55805 |
Toledo Clinic Cancer Centers-Oregon | Oregon, Ohio 43616 |
Community Howard Regional Health | Kokomo, Indiana 46904 |
Indiana University Health La Porte Hospital | La Porte, Indiana 46350 |