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
Results First Received: November 25, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Intervention: Drug: ixabepilone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was activated on September 16, 2004 and terminated on February 4, 2009 after reaching its accrual goal. A total of 124 patients were recruited from ECOG member institutions.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ixabepilone - no Prior Chemo All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
Ixabepilone - Prior Taxane All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
Ixabepilone - Two Prior Chemo All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.

Participant Flow:   Overall Study
    Ixabepilone - no Prior Chemo     Ixabepilone - Prior Taxane     Ixabepilone - Two Prior Chemo  
STARTED     39     49     36  
Treated     39     48     36  
Eligible and Treated     35     42     32  
Patients for the Analysis of PSA Respons     30     34     22  
Patients With Measurable Disease     22     25     24  
Patients With PSA Response     10     8     4  
Patients w/ Measurable Disease Response     5     2     0  
COMPLETED     0     0     0  
NOT COMPLETED     39     49     36  
Adverse Event                 18                 17                 13  
Death                 2                 1                 0  
Withdrawal by Subject                 3                 2                 2  
Physician Decision                 1                 1                 1  
Disease progression                 9                 19                 12  
Ineligible                 4                 7                 4  
Symptomatic deterioration                 1                 1                 3  
Use of coumadin                 1                 0                 0  
Response achieved                 0                 1                 0  
Extradural disease                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ixabepilone - no Prior Chemo All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
Ixabepilone - Prior Taxane All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
Ixabepilone - Two Prior Chemo All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
Total Total of all reporting groups

Baseline Measures
    Ixabepilone - no Prior Chemo     Ixabepilone - Prior Taxane     Ixabepilone - Two Prior Chemo     Total  
Number of Participants  
[units: participants]
  35     42     32     109  
Age  
[units: years]
Median ( Full Range )
  72  
  ( 45 to 82 )  
  69  
  ( 50 to 81 )  
  67.5  
  ( 49 to 90 )  
  70  
  ( 45 to 90 )  
Gender  
[units: participants]
       
Female     0     0     0     0  
Male     35     42     32     109  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


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