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Eribulin Mesylate in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00337077
First received: June 13, 2006
Last updated: May 21, 2014
Last verified: April 2014
Results First Received: February 14, 2014  
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
Hormone-refractory Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Intervention: Drug: eribulin mesylate

  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
Participants were recruited from ECOG member institutions between November 29, 2006 and August 5, 2009.

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
Chemonaive Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Prior Taxane Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Two Prior Chemotherapy Regimens Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Chemonaive     Prior Taxane     Two Prior Chemotherapy Regimens  
STARTED     43     53     25  
Treated     42     52     25  
Toxicity Assessed     42     51     25  
Eligible and Treated     41     51     24  
Patients With Measurable Disease     26     38     13  
COMPLETED     0 [1]   0 [1]   0 [1]
NOT COMPLETED     43     53     25  
Progressive disease                 25                 37                 19  
Adverse Event                 7                 7                 1  
Death                 0                 1                 0  
Withdrawal by Subject                 7                 2                 2  
Alternative therapy                 1                 0                 0  
Physician Decision                 1                 4                 2  
Never started treatment                 1                 1                 0  
Ineligible                 1                 1                 1  
[1] No completion of treatment because treatment was given until PD or unacceptable toxicity.



  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.
Eligible and treated patients are included in this analysis.

Reporting Groups
  Description
Chemonaive Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Prior Taxane Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Two Prior Chemotherapy Regimens Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
    Chemonaive     Prior Taxane     Two Prior Chemotherapy Regimens     Total  
Number of Participants  
[units: participants]
  41     51     24     116  
Age  
[units: years]
Median ( Full Range )
  70  
  ( 45 to 86 )  
  67  
  ( 45 to 88 )  
  73  
  ( 57 to 85 )  
  70  
  ( 45 to 88 )  
Gender  
[units: participants]
       
Female     0     0     0     0  
Male     41     51     24     116  
Region of Enrollment  
[units: participants]
       
United States     41     51     24     116  



  Outcome Measures
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1.  Primary:   Proportion of Patients With PSA Response   [ Time Frame: Assessed every 3 weeks during treatment; after off-treatment, every 3 months if patient is <2 years from study entry and every 6 months if patient is 2-5 years ]

2.  Secondary:   Proportion of Patients With Measurable Disease Response   [ Time Frame: Assessed every 9 weeks during treatment; after off-treatment, every 3 months if patient is <2 years from study entry and every 6 months if patient is 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
No text entered.


  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


Publications of Results:
Stein MN, Chen Y, Hudes GR, Carducci MA, Tan W, DiPaola RS. ECOG 5805: A phase II study of eribulin mesylate (E7389) in patients (pts) with metastatic castration-resistant prostate cancer (CRPC). J Clin Oncol 28:15s, 2010 (suppl; abstr 4556)


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00337077     History of Changes
Other Study ID Numbers: NCI-2009-00566, NCI-2009-00566, E5805, U10CA021115
Study First Received: June 13, 2006
Results First Received: February 14, 2014
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration