Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

124

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Sep 2004

Longer than P75 for phase_2

Geographic Reach

1 country

162 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.4 years study duration

First Submitted

Initial submission to the registry

July 8, 2004

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed

2 months until next milestone

Study Start

First participant enrolled

September 1, 2004

Completed

4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed

1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

December 27, 2012

Completed

Last Updated

May 9, 2014

Status Verified

April 1, 2013

Enrollment Period

4.6 years

First QC Date

July 8, 2004

Results QC Date

November 25, 2012

Last Update Submit

April 21, 2014

Conditions

Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

Proportion of Patients With Measurable Disease Response (Best Overall Response)
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
Duration of PSA Response
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
Duration of Measurable Disease Response
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

Study Arms (1)

Arm I

EXPERIMENTAL

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

Interventions

ixabepiloneDRUG

Given IV

Also known as: BMS-247550, epothilone B lactam, Ixempra

Arm I

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
+32 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (162)

The Medical Center of Aurora

Aurora, Colorado, 80012, United States

Location

Boulder Community Hospital

Boulder, Colorado, 80301, United States

Location

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States

Location

Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Exempla Saint Joseph Hospital

Denver, Colorado, 80218, United States

Location

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, 80218, United States

Location

Rose Medical Center

Denver, Colorado, 80220, United States

Location

Colorado Cancer Research Program CCOP

Denver, Colorado, 80224-2522, United States

Location

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, 81502, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

Saint Anthony Hospital

Lakewood, Colorado, 80228, United States

Location

Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States

Location

Longmont United Hospital

Longmont, Colorado, 80501, United States

Location

McKee Medical Center

Loveland, Colorado, 80539, United States

Location

Saint Mary Corwin Medical Center

Pueblo, Colorado, 81004, United States

Location

North Suburban Medical Center

Thornton, Colorado, 80229, United States

Location

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, 80033, United States

Location

Nanticoke Memorial Hospital

Seaford, Delaware, 19973, United States

Location

Saint Francis Hospital - Wilmington

Wilmington, Delaware, 19805, United States

Location

Edna Williams Cancer Center at the Baptist Cancer Institute

Jacksonville, Florida, 32207, United States

Location

Lakeland Regional Cancer Center

Lakeland, Florida, 33805, United States

Location

Rush - Copley Medical Center

Aurora, Illinois, 60504, United States

Location

Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital Association

Canton, Illinois, 61520, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Advocate Sherman Hospital

Elgin, Illinois, 60123, United States

Location

Alexian Brothers Medical and Cancer Center

Elk Grove Village, Illinois, 60007, United States

Location

Eureka Hospital

Eureka, Illinois, 61530, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare Galesburg

Galesburg, Illinois, 61401, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hopedale Medical Complex - Hospital

Hopedale, Illinois, 61747, United States

Location

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, 60435, United States

Location

Kewanee Hospital

Kewanee, Illinois, 61443, United States

Location

Mcdonough District Hospital

Macomb, Illinois, 61455, United States

Location

Garneau, Stewart C MD (UIA Investigator)