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Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

Primary Purpose

Adenocarcinoma of the Prostate, Hormone-refractory Prostate Cancer, Recurrent Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
eribulin mesylate
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate focused on measuring Eribulin Mesylate, metastatic hormone refractory prostate cancer, Halichondrin B Analog

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate Progressive metastatic disease or stable metastatic disease with rising PSA Previously treated with bilateral orchiectomy or other primary hormonal therapy with evidence of treatment failure Patients who have not undergone bilateral orchiectomy must continue luteinizing hormone-releasing hormone (LHRH)-agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist therapy (e.g. abarelix) while receiving study treatment Patients who did not have an orchiectomy must have a testosterone level < 50 ng/dL to confirm androgen suppression within the past 4 weeks ECOG performance status 0-2 Adequate bone marrow function Bilirubin =< 1.5 mg/dL Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper limit of normal Creatinine =< 2.0 mg/dL OR creatinine clearance >= 40 mL/min Fertile patients must use effective contraception A taxane-based regimen, mitoxantrone, or other cytotoxic chemotherapy regimen allowed provided there is evidence of disease progression At least 4 weeks since prior chemotherapy or radiotherapy At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and there is continued evidence of disease progression Disease progression after antiandrogen withdrawal must be confirmed by rising PSA after the required 4-6 week washout period (e.g., PSA level higher than the last PSA obtained while on antiandrogen therapy) More than 4 weeks since prior estrogen, estrogen-like agents (e.g., PC-SPES, saw palmetto, or other herbal products that may contain phytoestrogens), or any other hormonal therapy (including megestrol, finasteride, ketoconazole, or systemic corticosteroids) Concurrent bisphosphonates (e.g., pamidronate sodium or zoledronate) allowed provided the patient has been receiving the bisphosphonate for >= 4 weeks and there is evidence of disease progression Exclusion Criteria: Active angina pectoris Known New York Heart Association class III-IV heart disease Myocardial infarction within the past 6 months Evidence of ventricular dysrhythmias or other unstable arrhythmia (rate-controlled atrial fibrillation is allowed if the patient is asymptomatic from a cardiac standpoint) Peripheral neuropathy > grade 2 Other prior malignancy (excluding nonmelanomatous skin cancer treated with curative intent) unless the malignancy was treated with curative intent and the patient has been disease free for >= 5 years Serious concurrent medical illness or active infection that would preclude study treatment - No concurrent strong inhibitors or inducers of CYP3A4 More than 2 prior chemotherapy regimens for hormone-refractory disease - Other concurrent investigational agents Other concurrent anticancer therapy, including chemotherapy, gene therapy, biologic therapy, or immunotherapy Concurrent palliative radiotherapy Concurrent estrogen, estrogen-like agents, or any other hormonal therapy Carcinomatous meningitis or brain metastases Prior strontium chloride Sr 89, samarium 153 lexidronam pentasodium, or other radioisotopes Concurrent therapeutic anticoagulation with warfarin (Unfractionated heparin [standard, low-dose, or adjusted dose] or low molecular weight heparin allowed

Sites / Locations

  • Mayo Clinic in Arizona
  • Community Hospital of Monterey Peninsula
  • Manchester Memorial Hospital
  • Boca Raton Regional Hospital
  • Mayo Clinic in Florida
  • Rush - Copley Medical Center
  • Saint Joseph Medical Center
  • Graham Hospital Association
  • Memorial Hospital
  • Mercy Hospital and Medical Center
  • Decatur Memorial Hospital
  • Sherman Hospital
  • Eureka Hospital
  • Evanston CCOP-NorthShore University HealthSystem
  • Galesburg Cottage Hospital
  • Illinois CancerCare Galesburg
  • Mason District Hospital
  • Hopedale Medical Complex - Hospital
  • Joliet Oncology-Hematology Associates Limited
  • Kewanee Hospital
  • Mcdonough District Hospital
  • Garneau, Stewart C MD (UIA Investigator)
  • Porubcin, Michael MD (UIA Investigator)
  • Sharis, Christine M MD (UIA Investigator)
  • Stoffel, Thomas J MD (UIA Investigator)
  • Vigliotti, Antonio, P.G. M.D. (UIA Investigator)
  • Bromenn Regional Medical Center
  • Community Cancer Center Foundation
  • Illinois CancerCare-Ottawa Clinic
  • Ottawa Regional Hospital and Healthcare Center
  • Pekin Cancer Treatment Center
  • Pekin Hospital
  • Methodist Medical Center of Illinois
  • Proctor Hospital
  • Illinois CancerCare-Peoria
  • Illinois Oncology Research Association CCOP
  • OSF Saint Francis Medical Center
  • Illinois Valley Hospital
  • Perry Memorial Hospital
  • Edward H Kaplan MD and Associates
  • Saint Margaret's Hospital
  • Memorial Medical Center
  • Carle Clinic-Urbana Main
  • Carle Foundation - Carle Cancer Center
  • Elkhart General Hospital
  • Community Howard Regional Health
  • Indiana University Health La Porte Hospital
  • Saint Anthony Memorial Health Center
  • Saint Joseph Regional Medical Center-Mishawaka
  • Memorial Hospital of South Bend
  • Northern Indiana Cancer Research Consortium
  • McFarland Clinic
  • Constantinou, Costas L MD (UIA Investigator)
  • Cedar Rapids Oncology Association
  • Mercy Hospital
  • Oncology Associates at Mercy Medical Center
  • Mercy Capitol
  • Iowa Methodist Medical Center
  • Iowa Oncology Research Association CCOP
  • Medical Oncology and Hematology Associates-Des Moines
  • Medical Oncology and Hematology Associates
  • Mercy Medical Center - Des Moines
  • Iowa Lutheran Hospital
  • Siouxland Hematology Oncology Associates
  • Mercy Medical Center-Sioux City
  • Saint Luke's Regional Medical Center
  • Eastern Cooperative Oncology Group
  • Bixby Medical Center
  • Hickman Cancer Center
  • Saint Joseph Mercy Hospital
  • Michigan Cancer Research Consortium Community Clinical Oncology Program
  • Oakwood Hospital
  • Saint John Hospital and Medical Center
  • Green Bay Oncology - Escanaba
  • Hurley Medical Center
  • Genesys Regional Medical Center-West Flint Campus
  • Green Bay Oncology - Iron Mountain
  • Allegiance Health
  • Sparrow Hospital
  • Saint Mary Mercy Hospital
  • Community Cancer Center of Monroe
  • Mercy Memorial Hospital
  • Saint Joseph Mercy Oakland
  • Saint Joseph Mercy Port Huron
  • Saint Mary's of Michigan
  • Lakeland Hospital
  • Saint John Macomb-Oakland Hospital
  • Sanford Clinic North-Bemidgi
  • Essentia Health Duluth Clinic CCOP
  • Essentia Health Saint Mary's Medical Center
  • Miller-Dwan Hospital
  • Hutchinson Area Health Care
  • Meeker County Memorial Hospital
  • Saint John's Hospital - Healtheast
  • Virginia Piper Cancer Institute
  • Hennepin County Medical Center
  • Mayo Clinic
  • Regions Hospital
  • Saint Joseph's Hospital - Healtheast
  • Saint Francis Regional Medical Center
  • Woodwinds Health Campus
  • Hunterdon Medical Center
  • Hackensack University Medical CCOP
  • Cancer Institute of New Jersey At Hamilton
  • Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
  • Cancer Institute of New Jersey
  • Virtua West Jersey Hospital Voorhees
  • The North Division of Montefiore Medical Center
  • New York University Langone Medical Center
  • Sanford Clinic North-Fargo
  • Sanford Medical Center-Fargo
  • Toledo Clinic Cancer Centers-Bowling Green
  • Case Western Reserve University
  • North Coast Cancer Care-Clyde
  • Hematology Oncology Center Incorporated
  • Lima Memorial Hospital
  • Toledo Clinic Cancer Centers-Maumee
  • Saint Luke's Hospital
  • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
  • Saint Charles Hospital
  • Toledo Clinic Cancer Centers-Oregon
  • North Coast Cancer Care
  • Flower Hospital
  • Mercy Hospital of Tiffin
  • The Toledo Hospital/Toledo Children's Hospital
  • Saint Vincent Mercy Medical Center
  • University of Toledo
  • Toledo Community Hospital Oncology Program CCOP
  • Mercy Cancer Center at Saint Anne Mercy Hospital
  • Toledo Clinic Cancer Centers-Toledo
  • Fulton County Health Center
  • Abington Memorial Hospital
  • Saint Luke's Hospital
  • Penn State Milton S Hershey Medical Center
  • Lewistown Hospital
  • Mount Nittany Medical Center
  • Fredericksburg Oncology Inc
  • Green Bay Oncology at Saint Vincent Hospital
  • Saint Vincent Hospital
  • Green Bay Oncology Limited at Saint Mary's Hospital
  • Saint Mary's Hospital
  • UW Health Oncology - 1 South Park
  • University of Wisconsin Hospital and Clinics
  • Bay Area Medical Center
  • Green Bay Oncology - Oconto Falls
  • Green Bay Oncology - Sturgeon Bay
  • Riverview Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eribulin mesylate

Arm Description

Patients receive eribulin mesylate IV over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Proportion of Patients With PSA Response
PSA response is defined as a PSA decline from baseline value by >=50%, or normalization of PSA (<0.2 ng/ml) confirmed by a second measurement greater than or equal to 4 weeks later.

Secondary Outcome Measures

Proportion of Patients With Measurable Disease Response
Measurable disease response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Measurable disease response = CR + PR. Only patients with measurable disease at baseline are included in this analysis.

Full Information

First Posted
June 13, 2006
Last Updated
May 21, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00337077
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 Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate, Hormone-refractory Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer
Keywords
Eribulin Mesylate, metastatic hormone refractory prostate cancer, Halichondrin B Analog

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eribulin mesylate
Arm Type
Experimental
Arm Description
Patients receive eribulin mesylate IV over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
eribulin mesylate
Other Intervention Name(s)
B1939, E7389, ER-086526, halichrondrin B analog
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Proportion of Patients With PSA Response
Description
PSA response is defined as a PSA decline from baseline value by >=50%, or normalization of PSA (<0.2 ng/ml) confirmed by a second measurement greater than or equal to 4 weeks later.
Time Frame
Assessed every 3 weeks during treatment; after off-treatment, every 3 months if patient is <2 years from study entry and every 6 months if patient is 2-5 years
Secondary Outcome Measure Information:
Title
Proportion of Patients With Measurable Disease Response
Description
Measurable disease response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Measurable disease response = CR + PR. Only patients with measurable disease at baseline are included in this analysis.
Time Frame
Assessed every 9 weeks during treatment; after off-treatment, every 3 months if patient is <2 years from study entry and every 6 months if patient is 2-5 years from study entry

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate Progressive metastatic disease or stable metastatic disease with rising PSA Previously treated with bilateral orchiectomy or other primary hormonal therapy with evidence of treatment failure Patients who have not undergone bilateral orchiectomy must continue luteinizing hormone-releasing hormone (LHRH)-agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist therapy (e.g. abarelix) while receiving study treatment Patients who did not have an orchiectomy must have a testosterone level < 50 ng/dL to confirm androgen suppression within the past 4 weeks ECOG performance status 0-2 Adequate bone marrow function Bilirubin =< 1.5 mg/dL Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper limit of normal Creatinine =< 2.0 mg/dL OR creatinine clearance >= 40 mL/min Fertile patients must use effective contraception A taxane-based regimen, mitoxantrone, or other cytotoxic chemotherapy regimen allowed provided there is evidence of disease progression At least 4 weeks since prior chemotherapy or radiotherapy At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide) and there is continued evidence of disease progression Disease progression after antiandrogen withdrawal must be confirmed by rising PSA after the required 4-6 week washout period (e.g., PSA level higher than the last PSA obtained while on antiandrogen therapy) More than 4 weeks since prior estrogen, estrogen-like agents (e.g., PC-SPES, saw palmetto, or other herbal products that may contain phytoestrogens), or any other hormonal therapy (including megestrol, finasteride, ketoconazole, or systemic corticosteroids) Concurrent bisphosphonates (e.g., pamidronate sodium or zoledronate) allowed provided the patient has been receiving the bisphosphonate for >= 4 weeks and there is evidence of disease progression Exclusion Criteria: Active angina pectoris Known New York Heart Association class III-IV heart disease Myocardial infarction within the past 6 months Evidence of ventricular dysrhythmias or other unstable arrhythmia (rate-controlled atrial fibrillation is allowed if the patient is asymptomatic from a cardiac standpoint) Peripheral neuropathy > grade 2 Other prior malignancy (excluding nonmelanomatous skin cancer treated with curative intent) unless the malignancy was treated with curative intent and the patient has been disease free for >= 5 years Serious concurrent medical illness or active infection that would preclude study treatment - No concurrent strong inhibitors or inducers of CYP3A4 More than 2 prior chemotherapy regimens for hormone-refractory disease - Other concurrent investigational agents Other concurrent anticancer therapy, including chemotherapy, gene therapy, biologic therapy, or immunotherapy Concurrent palliative radiotherapy Concurrent estrogen, estrogen-like agents, or any other hormonal therapy Carcinomatous meningitis or brain metastases Prior strontium chloride Sr 89, samarium 153 lexidronam pentasodium, or other radioisotopes Concurrent therapeutic anticoagulation with warfarin (Unfractionated heparin [standard, low-dose, or adjusted dose] or low molecular weight heparin allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Stein, M.D.
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Community Hospital of Monterey Peninsula
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
Manchester Memorial Hospital
City
Manchester
State/Province
Connecticut
ZIP/Postal Code
06040
Country
United States
Facility Name
Boca Raton Regional Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-9980
Country
United States
Facility Name
Rush - Copley Medical Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Saint Joseph Medical Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Graham Hospital Association
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Memorial Hospital
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Mercy Hospital and Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Sherman Hospital
City
Elgin
State/Province
Illinois
ZIP/Postal Code
60123
Country
United States
Facility Name
Eureka Hospital
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Evanston CCOP-NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Galesburg Cottage Hospital
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare Galesburg
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Mason District Hospital
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Hopedale Medical Complex - Hospital
City
Hopedale
State/Province
Illinois
ZIP/Postal Code
61747
Country
United States
Facility Name
Joliet Oncology-Hematology Associates Limited
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Kewanee Hospital
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
Mcdonough District Hospital
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Garneau, Stewart C MD (UIA Investigator)
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Porubcin, Michael MD (UIA Investigator)
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Sharis, Christine M MD (UIA Investigator)
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Stoffel, Thomas J MD (UIA Investigator)
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Vigliotti, Antonio, P.G. M.D. (UIA Investigator)
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Bromenn Regional Medical Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Cancer Center Foundation
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Illinois CancerCare-Ottawa Clinic
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Ottawa Regional Hospital and Healthcare Center
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Pekin Cancer Treatment Center
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Pekin Hospital
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Proctor Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Illinois CancerCare-Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Illinois Oncology Research Association CCOP
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Illinois Valley Hospital
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Perry Memorial Hospital
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Edward H Kaplan MD and Associates
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Saint Margaret's Hospital
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
Carle Clinic-Urbana Main
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Carle Foundation - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Community Howard Regional Health
City
Kokomo
State/Province
Indiana
ZIP/Postal Code
46904
Country
United States
Facility Name
Indiana University Health La Porte Hospital
City
La Porte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
Saint Anthony Memorial Health Center
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
Saint Joseph Regional Medical Center-Mishawaka
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545-1470
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
McFarland Clinic
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Constantinou, Costas L MD (UIA Investigator)
City
Bettendorf
State/Province
Iowa
ZIP/Postal Code
52722
Country
United States
Facility Name
Cedar Rapids Oncology Association
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Mercy Hospital
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Oncology Associates at Mercy Medical Center
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Mercy Capitol
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50307
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Iowa Oncology Research Association CCOP
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
Siouxland Hematology Oncology Associates
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center-Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Saint Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Eastern Cooperative Oncology Group
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Bixby Medical Center
City
Adrian
State/Province
Michigan
ZIP/Postal Code
49221
Country
United States
Facility Name
Hickman Cancer Center
City
Adrian
State/Province
Michigan
ZIP/Postal Code
49221
Country
United States
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
Michigan Cancer Research Consortium Community Clinical Oncology Program
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Oakwood Hospital
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Saint John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Green Bay Oncology - Escanaba
City
Escanaba
State/Province
Michigan
ZIP/Postal Code
49431
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48502
Country
United States
Facility Name
Genesys Regional Medical Center-West Flint Campus
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Green Bay Oncology - Iron Mountain
City
Iron Mountain
State/Province
Michigan
ZIP/Postal Code
49801
Country
United States
Facility Name
Allegiance Health
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Saint Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
Community Cancer Center of Monroe
City
Monroe
State/Province
Michigan
ZIP/Postal Code
48162
Country
United States
Facility Name
Mercy Memorial Hospital
City
Monroe
State/Province
Michigan
ZIP/Postal Code
48162
Country
United States
Facility Name
Saint Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341-2985
Country
United States
Facility Name
Saint Joseph Mercy Port Huron
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Saint Mary's of Michigan
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Lakeland Hospital
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Saint John Macomb-Oakland Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Sanford Clinic North-Bemidgi
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Facility Name
Essentia Health Duluth Clinic CCOP
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Essentia Health Saint Mary's Medical Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Miller-Dwan Hospital
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Hutchinson Area Health Care
City
Hutchinson
State/Province
Minnesota
ZIP/Postal Code
55350
Country
United States
Facility Name
Meeker County Memorial Hospital
City
Litchfield
State/Province
Minnesota
ZIP/Postal Code
55355
Country
United States
Facility Name
Saint John's Hospital - Healtheast
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Saint Joseph's Hospital - Healtheast
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Saint Francis Regional Medical Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
Woodwinds Health Campus
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Hunterdon Medical Center
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
Facility Name
Hackensack University Medical CCOP
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cancer Institute of New Jersey At Hamilton
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Virtua West Jersey Hospital Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
The North Division of Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Sanford Clinic North-Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Sanford Medical Center-Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Toledo Clinic Cancer Centers-Bowling Green
City
Bowling Green
State/Province
Ohio
ZIP/Postal Code
43402
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
North Coast Cancer Care-Clyde
City
Clyde
State/Province
Ohio
ZIP/Postal Code
43410
Country
United States
Facility Name
Hematology Oncology Center Incorporated
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Lima Memorial Hospital
City
Lima
State/Province
Ohio
ZIP/Postal Code
45804
Country
United States
Facility Name
Toledo Clinic Cancer Centers-Maumee
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537-1839
Country
United States
Facility Name
Saint Luke's Hospital
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
Saint Charles Hospital
City
Oregon
State/Province
Ohio
ZIP/Postal Code
43616
Country
United States
Facility Name
Toledo Clinic Cancer Centers-Oregon
City
Oregon
State/Province
Ohio
ZIP/Postal Code
43616
Country
United States
Facility Name
North Coast Cancer Care
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
Flower Hospital
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Mercy Hospital of Tiffin
City
Tiffin
State/Province
Ohio
ZIP/Postal Code
44883
Country
United States
Facility Name
The Toledo Hospital/Toledo Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Saint Vincent Mercy Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Toledo Community Hospital Oncology Program CCOP
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Facility Name
Mercy Cancer Center at Saint Anne Mercy Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Toledo Clinic Cancer Centers-Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Fulton County Health Center
City
Wauseon
State/Province
Ohio
ZIP/Postal Code
43567
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Saint Luke's Hospital
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Lewistown Hospital
City
Lewistown
State/Province
Pennsylvania
ZIP/Postal Code
17044
Country
United States
Facility Name
Mount Nittany Medical Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16803
Country
United States
Facility Name
Fredericksburg Oncology Inc
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22401
Country
United States
Facility Name
Green Bay Oncology at Saint Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301-3526
Country
United States
Facility Name
Saint Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Green Bay Oncology Limited at Saint Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
Saint Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
UW Health Oncology - 1 South Park
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Bay Area Medical Center
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Green Bay Oncology - Oconto Falls
City
Oconto Falls
State/Province
Wisconsin
ZIP/Postal Code
54154
Country
United States
Facility Name
Green Bay Oncology - Sturgeon Bay
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54235
Country
United States
Facility Name
Riverview Hospital
City
Wisconsin Rapids
State/Province
Wisconsin
ZIP/Postal Code
54494
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Stein MN, Chen Y, Hudes GR, Carducci MA, Tan W, DiPaola RS. ECOG 5805: A phase II study of eribulin mesylate (E7389) in patients (pts) with metastatic castration-resistant prostate cancer (CRPC). J Clin Oncol 28:15s, 2010 (suppl; abstr 4556)
Results Reference
result

Learn more about this trial

Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

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