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A Phase II Trial of E7389 (Halichondrin B Analog), in Patients With Metastatic Hormone Refractory Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer

Thank you

Trial Information

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.


Inclusion Criteria:



- Histologically confirmed adenocarcinoma of the prostate

- Progressive (i.e., new lesions on bone scan or new/enlarging lesions on CT scan) or
stable metastatic disease*

- Patients with bone metastases only (i.e., lacking soft tissue disease) must have a
prostate-specific antigen (PSA) level >= 5 ng/mL within the past 1 week

- Patients with soft tissue metastases and/or visceral disease must have either
measurable disease OR a PSA level >= 5 ng/mL within the past 1 week

- Patients with stable metastases must have a rising PSA level within the past 4 weeks

- Two consecutive rises in PSA, each measurement taken >= 1 week apart

- [Note: *Radiologic evidence of hydronephrosis alone is not considered evidence of
metastatic disease]

- Meets 1 of the following criteria:

- Never received prior chemotherapy/cytotoxic therapy

- Received prior taxane-based regimen

- Received 2 prior cytotoxic chemotherapy regimens including, but not limited to,
prior taxane and anthracyclines

- 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

- Granulocyte count >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Bilirubin =< 1.5 mg/dL

- AST and ALT =< 2.5 times upper limit of normal

- Creatinine =< 2.0 mg/dL OR creatinine clearance >= 40 mL/min

- No active angina pectoris

- No known New York Heart Association class III-IV heart disease

- No myocardial infarction within the past 6 months

- No evidence of ventricular dysrhythmias or other unstable arrhythmia

- Rate-controlled atrial fibrillation is allowed if the patient is asymptomatic from a
cardiac standpoint

- No peripheral neuropathy > grade 2

- No 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

- No serious concurrent medical illness or active infection that would preclude study
treatment

- Fertile patients must use effective contraception

- No more than 2 prior chemotherapy regimens for hormone-refractory disease

- A taxane-based regimen, mitoxantrone, or other cytotoxic chemotherapy regimen allowed
provided there is evidence of disease progression

- Treatment with estramustine is not considered a separate cytotoxic regimen

- 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 and no concurrent 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)

- No prior strontium chloride Sr 89, samarium 153 lexidronam pentasodium, or other
radioisotopes

- No concurrent therapeutic anticoagulation with warfarin

- Unfractionated heparin (standard, low-dose, or adjusted dose) or low molecular weight
heparin allowed

- 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

- No concurrent strong inhibitors or inducers of CYP3A4

- No other concurrent investigational agents

- No other concurrent anticancer therapy, including chemotherapy, gene therapy,
biologic therapy, or immunotherapy

- No concurrent palliative radiotherapy

- No known carcinomatous meningitis or brain metastases

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients with a greater than or equal to 50% decrease in Prostate-specific antigen (PSA) levels

Outcome Time Frame:

Baseline and 4 weeks

Safety Issue:

No

Principal Investigator

Mark Stein

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00566

NCT ID:

NCT00337077

Start Date:

November 2006

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Hormone-resistant Prostate Cancer
  • Recurrent Prostate Cancer
  • Stage IV Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905
Abington Memorial HospitalAbington, Pennsylvania  19001
Hurley Medical CenterFlint, Michigan  48503
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
Lewistown HospitalLewistown, Pennsylvania  17044
Mount Nittany Medical CenterState College, Pennsylvania  16803
Elkhart General HospitalElkhart, Indiana  46515
Memorial HospitalCarthage, Illinois  62321
Mercy Hospital and Medical CenterChicago, Illinois  60616
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Proctor HospitalPeoria, Illinois  61614
Perry Memorial HospitalPrinceton, Illinois  61356
Community Cancer Center of MonroeMonroe, Michigan  48162
Wood County Oncology CenterBowling Green, Ohio  43402
Lima Memorial HospitalLima, Ohio  45804
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Mercy Hospital of TiffinTiffin, Ohio  44883
Fulton County Health CenterWauseon, Ohio  43567
Eureka HospitalEureka, Illinois  61530
Graham Hospital AssociationCanton, Illinois  61520
Saint Joseph Medical CenterJoliet, Illinois  60435
Pekin HospitalPekin, Illinois  61554
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Bixby Medical CenterAdrian, Michigan  49221
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Regions HospitalSaint Paul, Minnesota  55101
Saint Francis Regional Medical CenterShakopee, Minnesota  55379
Saint Luke's HospitalMaumee, Ohio  43537
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Mayo Clinic in FloridaJacksonville, Florida  32224
Manchester Memorial HospitalManchester, Connecticut  06040-4188
Sherman HospitalElgin, Illinois  60120-2198
Memorial Medical CenterSpringfield, Illinois  62781
Woodwinds Health CampusWoodbury, Minnesota  55125
Hennepin County Medical CenterMinneapolis, Minnesota  
Case Western Reserve UniversityCleveland, Ohio  44106
Toledo ClinicOregon, Ohio  43616
Flower HospitalSylvania, Ohio  43560-2197
Decatur Memorial HospitalDecatur, Illinois  62526
Oncology AssociatesCedar Rapids, Iowa  52403
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Penn State Milton S Hershey Medical CenterHershey, Pennsylvania  17033
OSF Saint Francis Medical CenterPeoria, Illinois  61637
Community Hospital of Monterey PeninsulaMonterey, California  93940
Rush - Copley Medical CenterAurora, Illinois  60504
Evanston CCOP-NorthShore University HealthSystemEvanston, Illinois  60201
Hopedale Medical Complex - HospitalHopedale, Illinois  61747
Joliet Oncology-Hematology Associates LimitedJoliet, 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 FoundationNormal, Illinois  61761
Illinois CancerCare-Ottawa ClinicOttawa, Illinois  61350
Ottawa Regional Hospital and Healthcare CenterOttawa, Illinois  61350
Pekin Cancer Treatment CenterPekin, Illinois  61554
Illinois Oncology Research Association CCOPPeoria, Illinois  61615
Illinois CancerCare-PeoriaPeoria, Illinois  61615
Illinois Valley HospitalPeru, Illinois  61354
Edward H Kaplan MD and AssociatesSkokie, Illinois  60076
Saint Margaret's HospitalSpring Valley, Illinois  61362
Carle Clinic-Urbana MainUrbana, Illinois  61801
Saint Anthony Memorial Health CenterMichigan City, Indiana  46360
Saint Joseph's Medical CenterSouth Bend, Indiana  46617
McFarland ClinicAmes, Iowa  50010
Constantinou, Costas L MD (UIA Investigator)Bettendorf, Iowa  52722
Cedar Rapids Oncology AssociationCedar Rapids, Iowa  52403
Mercy HospitalCedar Rapids, Iowa  52403
Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy CapitolDes Moines, Iowa  50307
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
Siouxland Hematology - Oncology AssociatesSioux City, Iowa  51101
Hickman Cancer CenterAdrian, Michigan  49221
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Green Bay Oncology - EscanabaEscanaba, Michigan  49431
Green Bay Oncology - Iron MountainIron Mountain, Michigan  49801
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Mercy Memorial HospitalMonroe, Michigan  48162
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Lakeland HospitalSt. Joseph, Michigan  49085
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Saint Mary's Medical CenterDuluth, Minnesota  55805
Miller-Dwan HospitalDuluth, Minnesota  55805
Saint John's Hospital - HealtheastMaplewood, Minnesota  55109
Saint Joseph's Hospital - HealtheastSaint Paul, Minnesota  55102
Hunterdon Medical CenterFlemington, New Jersey  08822
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington CountyMount Holly, New Jersey  08060
Virtua West Jersey Hospital VoorheesVoorhees, New Jersey  08043
The North Division of Montefiore Medical CenterBronx, New York  10466
New York University Langone Medical CenterNew York, New York  10016
Hematology Oncology Center IncorporatedElyria, Ohio  44035
Toledo Radiation Oncology at Northwest Ohio Onocolgy CenterMaumee, Ohio  43537
Saint Charles HospitalOregon, Ohio  43616
North Coast Cancer CareSandusky, Ohio  44870
Toledo Community Hospital Oncology Program CCOPToledo, Ohio  43617
Mercy Cancer Center at Saint Anne Mercy HospitalToledo, Ohio  43623
University of ToledoToledo, Ohio  43614
The Toledo HospitalToledo, Ohio  43606
Saint Vincent Mercy Medical CenterToledo, Ohio  43608
Saint Luke's HospitalBethlehem, Pennsylvania  18015
Fredericksburg Oncology IncFredericksburg, Virginia  22401
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's HospitalGreen Bay, Wisconsin  54303
Saint Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent HospitalGreen Bay, Wisconsin  54301-3526
UW Health Oncology - 1 South ParkMadison, Wisconsin  53715
Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology - Sturgeon BaySturgeon Bay, Wisconsin  54235
Hackensack University Medical CCOPHackensack, New Jersey  07601
North Coast Cancer Care-ClydeClyde, Ohio  43410
Riverview HospitalWisconsin Rapids, Wisconsin  54494
Boca Raton Regional HospitalBoca Raton, Florida  33486
Carle Foundation - Carle Cancer CenterUrbana, Illinois  61801
Sanford Clinic North-FargoFargo, North Dakota  58102
Sanford Medical Center-FargoFargo, North Dakota  58122
Eastern Cooperative Oncology GroupBoston, Massachusetts  02215
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Sanford Clinic North-BemidgiBemidji, Minnesota  56601
Essentia Health Duluth Clinic CCOPDuluth, Minnesota  55805
Toledo Clinic Cancer Centers-OregonOregon, Ohio  43616
Community Howard Regional HealthKokomo, Indiana  46904
Indiana University Health La Porte HospitalLa Porte, Indiana  46350