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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00337077
First received: June 13, 2006
Last updated: May 21, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Adenocarcinoma of the Prostate
Hormone-refractory Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Drug: eribulin mesylate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of E7389 (Halichondrin B Analog), in Patients With Metastatic Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of Patients With PSA Response [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 121
Study Start Date: November 2006
Study Completion Date: November 2013
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eribulin mesylate
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.
Drug: eribulin mesylate
Given IV
Other Names:
  • B1939
  • E7389
  • ER-086526
  • halichrondrin B analog

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337077

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, California
Community Hospital of Monterey Peninsula
Monterey, California, United States, 93940
United States, Connecticut
Manchester Memorial Hospital
Manchester, Connecticut, United States, 06040
United States, Florida
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital Association
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60616
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Sherman Hospital
Elgin, Illinois, United States, 60123
Eureka Hospital
Eureka, Illinois, United States, 61530
Evanston CCOP-NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Illinois CancerCare Galesburg
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Mason District Hospital
Havana, Illinois, United States, 62644
Hopedale Medical Complex - Hospital
Hopedale, Illinois, United States, 61747
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States, 60435
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Stoffel, Thomas J MD (UIA Investigator)
Moline, Illinois, United States, 61265
Vigliotti, Antonio, P.G. M.D. (UIA Investigator)
Moline, Illinois, United States, 61265
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, United States, 61265
Sharis, Christine M MD (UIA Investigator)
Moline, Illinois, United States, 61265
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, United States, 61265
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Pekin Hospital
Pekin, Illinois, United States, 61554
Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Edward H Kaplan MD and Associates
Skokie, Illinois, United States, 60076
Saint Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Foundation - Carle Cancer Center
Urbana, Illinois, United States, 61801
Carle Clinic-Urbana Main
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
Indiana University Health La Porte Hospital
La Porte, Indiana, United States, 46350
Saint Anthony Memorial Health Center
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
McFarland Clinic
Ames, Iowa, United States, 50010
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, United States, 52722
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, United States, 52403
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates
Des Moines, Iowa, United States, 50314
Mercy Capitol
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
United States, Massachusetts
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States, 02215
United States, Michigan
Hickman Cancer Center
Adrian, Michigan, United States, 49221
Bixby Medical Center
Adrian, Michigan, United States, 49221
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49431
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Hurley Medical Center
Flint, Michigan, United States, 48502
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Memorial Hospital
Monroe, Michigan, United States, 48162
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Lakeland Hospital
St. Joseph, Michigan, United States, 49085
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States, 56601
Essentia Health Duluth Clinic CCOP
Duluth, Minnesota, United States, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Litchfield, Minnesota, United States, 55355
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
Mayo Clinic
Rochester, Minnesota, United States, 55905
Saint Joseph's Hospital - Healtheast
Saint Paul, Minnesota, United States, 55102
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
United States, New Jersey
Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
Hackensack University Medical CCOP
Hackensack, New Jersey, United States, 07601
Cancer Institute of New Jersey At Hamilton
Hamilton, New Jersey, United States, 08690
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States, 08060
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Virtua West Jersey Hospital Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
The North Division of Montefiore Medical Center
Bronx, New York, United States, 10466
New York University Langone Medical Center
New York, New York, United States, 10016
United States, North Dakota
Sanford Clinic North-Fargo
Fargo, North Dakota, United States, 58122
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
United States, Ohio
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States, 43402
Case Western Reserve University
Cleveland, Ohio, United States, 44106
North Coast Cancer Care-Clyde
Clyde, Ohio, United States, 43410
Hematology Oncology Center Incorporated
Elyria, Ohio, United States, 44035
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States, 43537-1839
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States, 43537
Saint Luke's Hospital
Maumee, Ohio, United States, 43537
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States, 43616
Saint Charles Hospital
Oregon, Ohio, United States, 43616
North Coast Cancer Care
Sandusky, Ohio, United States, 44870
Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States, 43617
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States, 43623
Mercy Cancer Center at Saint Anne Mercy Hospital
Toledo, Ohio, United States, 43623
University of Toledo
Toledo, Ohio, United States, 43614
Fulton County Health Center
Wauseon, Ohio, United States, 43567
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Saint Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
United States, Virginia
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States, 22401
United States, Wisconsin
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
UW Health Oncology - 1 South Park
Madison, Wisconsin, United States, 53715
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Riverview Hospital
Wisconsin Rapids, Wisconsin, United States, 54494
Sponsors and Collaborators
Investigators
Study Chair: Mark Stein, M.D. Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
Publications:
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)

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00337077     History of Changes
Other Study ID Numbers: NCI-2009-00566, NCI-2009-00566, E5805, U10CA021115
Study First Received: June 13, 2006
Results First Received: February 14, 2014
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
Eribulin Mesylate
metastatic hormone refractory prostate cancer
Halichondrin B Analog

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014