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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 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