Ixabepilone in Treating Patients With Metastatic Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00087139
First received: July 8, 2004
Last updated: April 21, 2014
Last verified: April 2013
  Purpose

Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy.


Condition Intervention Phase
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Drug: ixabepilone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of a Weekly Schedule of BMS-247550 for Patients With 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: Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry ] [ Designated as safety issue: No ]
    PSA response is defined as a decline from baseline value by >=50%, or normalization of PSA (PSA < 0.2 ng/lm), confirmed by a second measurement >= 4 weeks later. The proportion of patients with PSA response was reported separately for 3 strata. Additional patients accrued to this study were not included in this analysis.


Secondary Outcome Measures:
  • Proportion of Patients With Measurable Disease Response (Best Overall Response) [ Time Frame: Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry ] [ Designated as safety issue: No ]

    Only patients with measurable disease were included in this analysis. The proportion of patients with measurable disease response (based on RECIST: Response Evaluation Criteria in Solid Tumors) was reported separately for 3 strata.

    Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget 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.

    Objective response = CR + PR


  • Duration of PSA Response [ Time Frame: Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry ] [ Designated as safety issue: No ]
    Duration of PSA response was defined as the time from the date of onset of PSA response until the date the criteria were met for PSA progression. Only patients with a PSA response were included in this analysis. The results were reported separately for 3 strata.

  • Duration of Measurable Disease Response [ Time Frame: Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry ] [ Designated as safety issue: No ]
    Duration of measurable disease response was defined as the time from the date when measurement criteria were met for complete or partial response, whichever status was recorded first, until the first date that recurrent or progressive disease was objectively documented based on RECIST (Response Evaluation Criteria in Solid Tumors). Only patients with measurable disease response were included in this analysis.


Enrollment: 124
Study Start Date: September 2004
Study Completion Date: February 2011
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I

Patients are stratified according to prior chemotherapy (none vs 1 prior taxane-containing regimen vs 2 prior cytotoxic regimens).

Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: ixabepilone
Given IV
Other Names:
  • BMS-247550
  • epothilone B lactam
  • Ixempra

Detailed Description:

PRIMARY OBJECTIVE:

I. To determine the effect on percent with a 50% decrease in PSA response in patients with metastatic prostate cancer who have progressed on androgen ablation therapy and are classified into 1 of 3 separate categories:

  1. Never received prior chemotherapy/cytotoxic therapy
  2. Received prior taxane-based regimen
  3. Received 2 prior cytotoxic chemotherapy regimens (including, but not limited to, prior taxane and anthracyclines)

SECONDARY OBJECTIVES:

I. Determine measurable disease response in patients with measurable disease treated with this drug and overall response rate.

II. Determine the toxic effects of this drug in these patients. III. Determine the duration of PSA and measurable disease response in patients treated with this drug.

IV. Determine the expression of p53, multidrug resistance protein, and Bcl-2 by immunohistochemistry in the primary tumors of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (none vs 1 prior taxane-containing regimen vs 2 prior cytotoxic regimens).

Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 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
  • Metastatic disease
  • Evidence of disease progression (e.g., new lesions on bone scan or new/enlarging lesions on CT scan) OR rising prostate-specific antigen (PSA) within the past 4 weeks
  • Radiologic evidence of hydronephrosis alone is not considered evidence of metastatic disease (e.g., increasing PSA)
  • Patients with bone metastases only (i.e., lacking soft tissue disease) must have a PSA level >= 10 ng/mL within the past week
  • Patients with stable disease and rising PSA must show 2 consecutive rises in PSA measurements taken at least 2 weeks apart
  • Most recent PSA level must be obtained within the past 4 weeks
  • Disease progression after prior anti-androgen withdrawal must be confirmed by a rising PSA after the 4-6 week washout period (e.g., PSA level higher than the last PSA obtained while on anti-androgen therapy)
  • Failed prior bilateral orchiectomy or other primary hormonal therapy
  • Patients who have not undergone bilateral orchiectomy must continue on luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist (e.g., abarelix) during study treatment AND must have a serum testosterone level =< 50 ng/dL within the past 4 weeks to confirm androgen suppression
  • ECOG 0-2
  • Granulocyte count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • WBC >= 4,000/mm^3
  • SGPT =< 2 times upper limit of normal
  • Bilirubin =< 1.5 mg/dL
  • INR normal
  • Creatinine =< 1.5 mg/dL
  • Creatinine clearance >= 50 mL/min
  • No New York Heart Association class III-IV heart disease
  • No myocardial infarction within the past 6 months
  • No active angina pectoris
  • No evidence of ventricular dysrhythmias or other unstable arrhythmia
  • Rate-controlled atrial fibrillation allowed provided the patient is asymptomatic
  • No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer
  • No serious medical illness or active infection that would preclude study participation
  • No concurrent prophylactic filgrastim (G-CSF)
  • No more than 2 prior cytotoxic chemotherapy regimens for hormone-refractory disease
  • At least 4 weeks since prior chemotherapy with a taxane-based regimen, mixantrone, or another cytotoxic chemotherapy regimen provided there is evidence of progressive disease
  • At least 4 weeks since prior flutamide AND continued evidence of progressive disease
  • At least 6 weeks since prior bicalutamide or nilutamide AND continued evidence of progressive disease
  • At least 4 weeks since prior estrogen or estrogen-like agents (e.g., PC-SPES, saw palmetto, or other herbal products which may contain phytoestrogens)
  • At least 4 weeks since prior hormonal therapy, including megestrol, finasteride, ketoconazole, or systemic corticosteroids
  • No concurrent estrogen or estrogen-like agents (e.g., PC-SPES, saw palmetto, or other herbal products which may contain phytoestrogens)
  • More than 4 weeks since prior radiotherapy
  • No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
  • No other prior radioisotope
  • No concurrent radiotherapy for pain control
  • No more than 1 prior experimental (non-cytotoxic) therapy AND evidence of progressive disease
  • At least 4 weeks since prior experimental therapy
  • Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed provided treatment was initiated at least 4 weeks ago and there is evidence of progressive disease
  • No other concurrent investigational agents
  • No concurrent therapeutic warfarin
  • Concurrent prophylactic or therapeutic doses of low molecular weight heparin allowed provided criterion for INR is met
  • No carcinomatous meningitis or brain metastases
  • Fertile patients must use effective contraception
  • No peripheral neuropathy > grade 1
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00087139

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Locations
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Rose Medical Center
Denver, Colorado, United States, 80220
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Swedish Medical Center
Englewood, Colorado, United States, 80113
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Delaware
Nanticoke Memorial Hospital
Seaford, Delaware, United States, 19973
Saint Francis Hospital - Wilmington
Wilmington, Delaware, United States, 19805
United States, Florida
Edna Williams Cancer Center at the Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
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
Advocate Sherman Hospital
Elgin, Illinois, United States, 60123
Alexian Brothers Medical and Cancer Center
Elk Grove Village, Illinois, United States, 60007
Eureka Hospital
Eureka, Illinois, United States, 61530
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
Sharis, Christine M MD (UIA Investigator)
Moline, Illinois, United States, 61265
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, United States, 61265
Stoffel, Thomas J MD (UIA Investigator)
Moline, Illinois, United States, 61265
Vigliotti, Antonio, P.G. M.D. (UIA Investigator)
Moline, Illinois, United States, 61265
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, United States, 61265
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Pekin Hospital
Pekin, Illinois, United States, 61554
Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Proctor Hospital
Peoria, Illinois, United States, 61614
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States, 61615
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Saint Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
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
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Saint Joseph Regional Medical Center - Mishawaka
Plymouth, Indiana, United States, 46544
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46628
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
South Bend Clinic
South Bend, Indiana, United States, 46617
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, United States, 52722
Saint Anthony Regional Hospital
Carroll, Iowa, United States, 51401
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, United States, 52403
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Saint Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Alegent Health Mercy Hospital
Council Bluffs, Iowa, United States, 51503
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Mercy Capitol
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Community Memorial Hospital
Missouri Valley, Iowa, United States, 51555
Burgess Memorial Hospital
Onawa, Iowa, United States, 51040
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101-1733
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States, 02215
Morton Hospital and Medical Center
Taunton, Massachusetts, United States, 02780
United States, Michigan
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
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
Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, United States, 49008
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
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
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Essentia Health Duluth Clinic CCOP
Duluth, Minnesota, United States, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Meeker County Memorial Hospital
Litchfield, Minnesota, United States, 55355
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
Saint Joseph's Hospital - Healtheast
Saint Paul, Minnesota, United States, 55102
Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
United States, Nebraska
Fremont Area Medical Center
Fremont, Nebraska, United States, 68025
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510
Bryan LGH Medical Center East
Lincoln, Nebraska, United States, 68506
Bryan LGH Medical Center West
Lincoln, Nebraska, United States, 68502
Midlands Community Hospital
Papillion, Nebraska, United States, 68046
United States, New Jersey
Ocean Medical Center
Brick, New Jersey, United States, 08724
Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
Cancer Institute of New Jersey At Hamilton
Hamilton, New Jersey, United States, 08690
Mountainside Hospital
Montclair, New Jersey, United States, 07042
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
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
Overlook Hospital
Summit, New Jersey, United States, 07902
Virtua West Jersey Hospital Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Montefiore Medical Center
Bronx, New York, United States, 10467-2490
Montefiore Medical Center-Wakefield Campus
Bronx, New York, United States, 10466
Mary Imogene Bassett Hospital
Cooperstown, New York, United States, 13326
United States, Ohio
Mercy Medical Center
Canton, Ohio, United States, 44708
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States, 18015
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Mainline Health CCOP
Wynnewood, Pennsylvania, United States, 19096
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, South Dakota
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Medical X-Ray Center
Sioux Falls, South Dakota, United States, 57105
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Wisconsin
Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States, 53038
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
UW Health Oncology - 1 South Park
Madison, Wisconsin, United States, 53715
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
Sponsors and Collaborators
Investigators
Principal Investigator: Glenn Liu Eastern Cooperative Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00087139     History of Changes
Other Study ID Numbers: NCI-2009-00548, NCI-2009-00548, CDR0000372946, E3803, E3803, E3803, U10CA021115
Study First Received: July 8, 2004
Results First Received: November 25, 2012
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration

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
Epothilone B
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014