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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00087139
Other study ID # NCI-2009-00548
Secondary ID NCI-2009-00548CD
Status Completed
Phase Phase 2
First received July 8, 2004
Last updated April 21, 2014
Start date September 2004
Est. completion date February 2011

Study information

Verified date April 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date February 2011
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

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


Intervention

Drug:
ixabepilone
Given IV

Locations

Country Name City State
United States Lehigh Valley Hospital Allentown Pennsylvania
United States McFarland Clinic PC-William R Bliss Cancer Center Ames Iowa
United States Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Rush - Copley Medical Center Aurora Illinois
United States The Medical Center of Aurora Aurora Colorado
United States Greater Baltimore Medical Center Baltimore Maryland
United States Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania
United States Constantinou, Costas L MD (UIA Investigator) Bettendorf Iowa
United States Saint Joseph Medical Center Bloomington Illinois
United States Eastern Cooperative Oncology Group Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
United States Ocean Medical Center Brick New Jersey
United States Albert Einstein College of Medicine Bronx New York
United States Montefiore Medical Center Bronx New York
United States Montefiore Medical Center-Wakefield Campus Bronx New York
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Graham Hospital Association Canton Illinois
United States Mercy Medical Center Canton Ohio
United States Saint Anthony Regional Hospital Carroll Iowa
United States Memorial Hospital Carthage Illinois
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 Saint Luke's Hospital Cedar Rapids Iowa
United States MetroHealth Medical Center Cleveland Ohio
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Mary Imogene Bassett Hospital Cooperstown New York
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Oakwood Hospital Dearborn Michigan
United States Colorado Cancer Research Program CCOP Denver Colorado
United States Exempla Saint Joseph Hospital Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rose Medical Center Denver Colorado
United States Iowa Lutheran Hospital 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 Capitol Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Saint John Hospital and Medical Center Detroit 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 Sacred Heart Hospital Eau Claire Wisconsin
United States Advocate Sherman Hospital Elgin Illinois
United States Alexian Brothers Medical and Cancer Center Elk Grove Village Illinois
United States Elkhart General Hospital Elkhart Indiana
United States Swedish Medical Center Englewood Colorado
United States Green Bay Oncology - Escanaba Escanaba Michigan
United States Eureka Hospital Eureka Illinois
United States Hunterdon Medical Center Flemington New Jersey
United States Genesys Regional Medical Center-West Flint Campus Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Fremont Area Medical Center Fremont Nebraska
United States Galesburg Cottage Hospital Galesburg Illinois
United States Illinois CancerCare Galesburg Galesburg Illinois
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States North Colorado Medical Center Greeley Colorado
United States Green Bay Oncology at 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 Saint Vincent Hospital Green Bay Wisconsin
United States Cancer Institute of New Jersey At Hamilton Hamilton New Jersey
United States Mason District Hospital Havana Illinois
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States Hopedale Medical Complex - Hospital Hopedale Illinois
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States Allegiance Health Jackson Michigan
United States Edna Williams Cancer Center at the Baptist Cancer Institute Jacksonville Florida
United States UW Cancer Center Johnson Creek Johnson Creek Wisconsin
United States Joliet Oncology-Hematology Associates Limited Joliet Illinois
United States Kalamazoo Center for Medical Studies Kalamazoo Michigan
United States Kewanee Hospital Kewanee Illinois
United States Community Howard Regional Health Kokomo Indiana
United States Gundersen Lutheran La Crosse Wisconsin
United States Indiana University Health La Porte Hospital La Porte Indiana
United States Lakeland Regional Cancer Center Lakeland Florida
United States Saint Anthony Hospital Lakewood Colorado
United States Sparrow Hospital Lansing Michigan
United States Lewistown Hospital Lewistown Pennsylvania
United States Bryan LGH Medical Center East Lincoln Nebraska
United States Bryan LGH Medical Center West Lincoln Nebraska
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States Meeker County Memorial Hospital Litchfield Minnesota
United States Saint Mary Mercy Hospital Livonia Michigan
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 Mcdonough District Hospital Macomb Illinois
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States UW Health Oncology - 1 South Park Madison Wisconsin
United States Bay Area Medical Center Marinette Wisconsin
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Virginia Piper Cancer Institute Minneapolis Minnesota
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Community Memorial Hospital Missouri Valley Iowa
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 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 Bromenn Regional Medical Center Normal Illinois
United States Community Cancer Center Foundation Normal Illinois
United States Green Bay Oncology - Oconto Falls Oconto Falls Wisconsin
United States Burgess Memorial Hospital Onawa Iowa
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Midlands Community Hospital Papillion Nebraska
United States Pekin Cancer Treatment Center Pekin Illinois
United States Pekin Hospital Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Illinois Oncology Research Association CCOP Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois Valley Hospital Peru Illinois
United States Saint Joseph Regional Medical Center - Mishawaka Plymouth Indiana
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Saint Joseph Mercy Port Huron Port Huron Michigan
United States Perry Memorial Hospital Princeton Illinois
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Marshfield Clinic-Rice Lake Center Rice Lake Wisconsin
United States Saint Mary's of Michigan Saginaw Michigan
United States Saint Joseph's Hospital - Healtheast Saint Paul Minnesota
United States Nanticoke Memorial Hospital Seaford Delaware
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Hematology Oncology Associates Sioux City Iowa
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Medical X-Ray Center Sioux Falls South Dakota
United States Sanford Cancer Center-Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Memorial Hospital of South Bend South Bend Indiana
United States Northern Indiana Cancer Research Consortium South Bend Indiana
United States South Bend Clinic South Bend Indiana
United States Saint Margaret's Hospital Spring Valley Illinois
United States Memorial Medical Center Springfield Illinois
United States Lakeland Hospital St. Joseph Michigan
United States Mount Nittany Medical Center State College Pennsylvania
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Overlook Hospital Summit New Jersey
United States Morton Hospital and Medical Center Taunton Massachusetts
United States North Suburban Medical Center Thornton Colorado
United States Carle Clinic-Urbana Main Urbana Illinois
United States Virtua West Jersey Hospital Voorhees Voorhees New Jersey
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Marshfield Clinic - Weston Center Weston Wisconsin
United States Exempla Lutheran Medical Center Wheat Ridge Colorado
United States Saint Francis Hospital - Wilmington Wilmington Delaware
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Woodwinds Health Campus Woodbury Minnesota
United States Lankenau Hospital Wynnewood Pennsylvania
United States Mainline Health CCOP Wynnewood Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Patients With PSA Response 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. 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 No
Secondary Proportion of Patients With Measurable Disease Response (Best Overall Response) 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
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 No
Secondary Duration of PSA Response 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. 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 No
Secondary Duration of Measurable Disease Response 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. 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 No
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