--- title: Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy nct_id: NCT00337077 overall_status: COMPLETED phase: PHASE2 sponsor: National Cancer Institute (NCI) study_type: INTERVENTIONAL primary_condition: Adenocarcinoma of the Prostate countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00337077.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00337077" ct_last_update_post_date: 2014-06-23 last_seen_at: "2026-05-12T06:27:54.885Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **NCT ID:** [NCT00337077](https://clinicaltrials.gov/study/NCT00337077) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 121 - **Lead Sponsor:** National Cancer Institute (NCI) - **Conditions:** Adenocarcinoma of the Prostate, Hormone-refractory Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer - **Start Date:** 2006-11 - **Completion Date:** 2013-11 - **CT.gov Last Update:** 2014-06-23 ## 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 - **Sex:** MALE - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Eribulin mesylate** (EXPERIMENTAL) — 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. ## Interventions - **eribulin mesylate** (DRUG) — Given IV ## Primary Outcomes - **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)_ — 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 Outcomes - **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)_ ## Locations (147) - 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, Saint 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 Township, New Jersey, United States - New York University Langone Medical Center, New York, New York, United States - The North Division of Montefiore Medical Center, The Bronx, 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 ## Recent Field Changes (last 30 days) - `locations.eureka hospital|eureka|illinois|united states` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.mayo clinic in arizona|scottsdale|arizona|united states` — added _(2026-05-12)_ - 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