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17-AAG in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00118092
First received: July 8, 2005
Last updated: March 20, 2017
Last verified: March 2017
Results First Received: December 28, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Interventions: Drug: tanespimycin
Other: laboratory biomarker analysis

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment (Tanespimycin) Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Tanespimycin)
STARTED   17 
COMPLETED   15 
NOT COMPLETED   2 
Withdrawal by Subject                1 
Protocol Violation                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.
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Reporting Groups
  Description
Treatment (Tanespimycin) Patients receive 300 mg/m^2 17-N-allylamino 17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 8, and 15. > Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Baseline Measures
   Treatment (Tanespimycin) 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Years]
Median (Full Range)
 68 
 (52 to 78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      15 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   15 


  Outcome Measures
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1.  Primary:   PSA Response as Defined by the Recommendations of the Prostate-Specific Antigen Working Group   [ Time Frame: Up to 1 year ]

2.  Secondary:   Proportion of Overall Responses   [ Time Frame: Up to 3 years ]

3.  Secondary:   Overall Survival   [ Time Frame: From registration to death due to any cause, assessed up to 3 years ]

4.  Secondary:   Disease-free Survival   [ Time Frame: From registration to documentation of disease progression, assessed up to 3 years ]

5.  Secondary:   Duration of PSA Response and PSA Control   [ Time Frame: From PSA response to time of progression, assessed up to 1 year ]


  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: Elisabeth Iljas Heath, M.D.
Organization: Karmanos Cancer Institute at Wayne State University
e-mail: heathe@karmanos.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00118092     History of Changes
Other Study ID Numbers: NCI-2012-01466
NCI-2012-01466 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MAYO-MC0453
NCI-6651
CDR0000433492
MC0453 ( Other Identifier: Mayo Clinic )
6651 ( Other Identifier: CTEP )
N01CM62205 ( US NIH Grant/Contract Award Number )
Study First Received: July 8, 2005
Results First Received: December 28, 2016
Last Updated: March 20, 2017