Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00459810
First received: April 11, 2007
Last updated: March 28, 2012
Last verified: March 2012
Results First Received: May 25, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: transdermal estradiol
Drug: paclitaxel poliglumex

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty-one patients enrolled in the trial between March 2007 and May 2008 in the medical clinics at Oregon Health & Science University and the University of California at San Francisco.

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
Transdermal Estradiol and Paclitaxel Poliglumex All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.

Participant Flow:   Overall Study
    Transdermal Estradiol and Paclitaxel Poliglumex  
STARTED     21  
COMPLETED     21  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Transdermal Estradiol and Paclitaxel Poliglumex All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.

Baseline Measures
    Transdermal Estradiol and Paclitaxel Poliglumex  
Number of Participants  
[units: participants]
  21  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     17  
Age  
[units: years]
Mean ± Standard Deviation
  70  ± 7.6  
Gender  
[units: participants]
 
Female     0  
Male     21  
Region of Enrollment  
[units: participants]
 
United States     21  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Prostate Specific Antigen (PSA) Response Rate: Number of Subjects With Decreases in PSA of at Least 50%   [ Time Frame: While receiving study agents (on average, 3 months) ]

2.  Secondary:   Measurable Disease Response Rate (Soft Tissue)   [ Time Frame: While receiving study agents (on average, 3 months) ]

3.  Secondary:   Time to Disease Progression   [ Time Frame: At time of progression by PSA or RECIST criteria ]

4.  Secondary:   Time to Death   [ Time Frame: Measured at Date of Death from any cause ]

5.  Secondary:   Correlation of Levels of Serum Estradiol, Serum Cathepsin B, and Bone Turnover Markers With PSA Response   [ Time Frame: Measured after 4 cycles of combination therapy ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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 less than or equal to 60 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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Study Coordinator
Organization: Oregon Health & Science University Knight Cancer Institute
phone: (503) 494-2897
e-mail: eilersk@ohsu.edu


No publications provided


Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00459810     History of Changes
Other Study ID Numbers: CDR0000540438, OHSU-2656
Study First Received: April 11, 2007
Results First Received: May 25, 2010
Last Updated: March 28, 2012
Health Authority: United States: Food and Drug Administration