Ixabepilone in Treating Patients With Metastatic Prostate Cancer
NCT ID: NCT00087139
Last Updated: 2014-05-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2004-09-30
2011-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
ixabepilone
Given IV
Interventions
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ixabepilone
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Glenn Liu
Role: PRINCIPAL_INVESTIGATOR
Eastern Cooperative Oncology Group
Locations
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The Medical Center of Aurora
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Exempla Saint Joseph Hospital
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Colorado Cancer Research Program CCOP
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
North Suburban Medical Center
Thornton, Colorado, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States
Nanticoke Memorial Hospital
Seaford, Delaware, United States
Saint Francis Hospital - Wilmington
Wilmington, Delaware, United States
Edna Williams Cancer Center at the Baptist Cancer Institute
Jacksonville, Florida, United States
Lakeland Regional Cancer Center
Lakeland, 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
Advocate Sherman Hospital
Elgin, Illinois, United States
Alexian Brothers Medical and Cancer Center
Elk Grove Village, Illinois, United States
Eureka Hospital
Eureka, 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
Saint Margaret's Hospital
Spring Valley, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Carle Clinic-Urbana Main
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
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center - Mishawaka
Plymouth, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, United States
Saint Anthony Regional Hospital
Carroll, Iowa, United States
Saint Luke's Hospital
Cedar Rapids, 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
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States
Alegent Health Mercy Hospital
Council Bluffs, 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-Laurel
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
Community Memorial Hospital
Missouri Valley, Iowa, United States
Burgess Memorial Hospital
Onawa, Iowa, United States
Siouxland Regional Cancer Center
Sioux City, 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
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States
Morton Hospital and Medical Center
Taunton, Massachusetts, 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
Kalamazoo Center for Medical Studies
Kalamazoo, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Saint Mary Mercy Hospital
Livonia, 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
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
Meeker County Memorial Hospital
Litchfield, Minnesota, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Saint Joseph's Hospital - Healtheast
Saint Paul, Minnesota, United States
Woodwinds Health Campus
Woodbury, Minnesota, United States
Fremont Area Medical Center
Fremont, Nebraska, United States
Bryan LGH Medical Center West
Lincoln, Nebraska, United States
Bryan LGH Medical Center East
Lincoln, Nebraska, United States
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, United States
Midlands Community Hospital
Papillion, Nebraska, United States
Ocean Medical Center
Brick, New Jersey, United States
Hunterdon Medical Center
Flemington, New Jersey, United States
Cancer Institute of New Jersey At Hamilton
Hamilton, New Jersey, United States
Mountainside Hospital
Montclair, New Jersey, United States
Morristown Memorial Hospital
Morristown, 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
Overlook Hospital
Summit, New Jersey, United States
Virtua West Jersey Hospital Voorhees
Voorhees Township, New Jersey, United States
Mary Imogene Bassett Hospital
Cooperstown, New York, United States
Albert Einstein College of Medicine
The Bronx, New York, United States
Montefiore Medical Center-Wakefield Campus
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Mercy Medical Center
Canton, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Lewistown Hospital
Lewistown, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Mount Nittany Medical Center
State College, Pennsylvania, United States
Lankenau Hospital
Wynnewood, Pennsylvania, United States
Mainline Health CCOP
Wynnewood, Pennsylvania, United States
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States
Medical X-Ray Center
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Sacred Heart Hospital
Eau Claire, Wisconsin, 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 Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States
Gundersen Lutheran
La Crosse, 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
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
Countries
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Other Identifiers
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NCI-2009-00548
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000372946
Identifier Type: -
Identifier Source: secondary_id
E3803
Identifier Type: -
Identifier Source: secondary_id
E3803
Identifier Type: OTHER
Identifier Source: secondary_id
E3803
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00548
Identifier Type: -
Identifier Source: org_study_id
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