Docetaxel in Treating Patients With Relapsed Prostate Cancer

This study has been terminated.
(Drug supplier stopped funding due to loss of study drug (docetaxel) patent.)
Sponsor:
Collaborator:
Information provided by:
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00482274
First received: June 4, 2007
Last updated: July 5, 2011
Last verified: July 2011
Results First Received: July 27, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: docetaxel

  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
Three subjects were enrolled between 11/08 and 4/09 from the oncology clinic at OHSU. Enrollment was terminated on 11/30/09, when the sponsor withdrew funding for this study.

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
Docetaxel Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.

Participant Flow:   Overall Study
    Docetaxel  
STARTED     3  
COMPLETED     2  
NOT COMPLETED     1  
Adverse Event                 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
Docetaxel Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.

Baseline Measures
    Docetaxel  
Number of Participants  
[units: participants]
  3  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation
  66  ± 2.49  
Gender  
[units: participants]
 
Female     0  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml   [ Time Frame: While receiving study treatment (approximately 6 months) ]

2.  Secondary:   Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)   [ Time Frame: Average days to develop recurrence from treatment start date amount applicable participants ]

3.  Secondary:   Time to Metastatic Disease   [ Time Frame: Measured at Time of documented metastases (no historical estimate is available) ]

4.  Secondary:   Time to Androgen Independent State   [ Time Frame: Measured at date of documented androgen independence (no estimate available) ]

5.  Secondary:   Time to Death From Any Cause   [ Time Frame: measured at date of death (no estimate available) ]


  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
Due to withdrawal of sponsor support, this study was terminated after only 3 subjects were enrolled (of the planned 36 subjects). Sufficient data were not obtained to make statistically significant conclusions.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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: Tomasz M. Beer, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00482274     History of Changes
Other Study ID Numbers: CDR0000546975, P30CA069533, OHSU-2838, OHSU-SOL-06076-LM
Study First Received: June 4, 2007
Results First Received: July 27, 2010
Last Updated: July 5, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration