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Perifosine in Treating Patients With Recurrent Prostate Cancer

This study has been terminated.
(Did not meet interim stopping criteria for continuation to the second stage.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00058214
First received: April 7, 2003
Last updated: February 9, 2015
Last verified: February 2013
Results First Received: February 9, 2015  
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 IIB Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Interventions: Drug: perifosine
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
No text entered.

Reporting Groups
  Description
Treatment (Perifosine)

Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.

perifosine: Given orally

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Perifosine)
STARTED   25 
COMPLETED   24 
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
Treatment (Perifosine)

Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.

perifosine: Given orally

laboratory biomarker analysis: Correlative studies


Baseline Measures
   Treatment (Perifosine) 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Years]
Median (Full Range)
 67 
 (52 to 78) 
Gender 
[Units: Participants]
 
Female   0 
Male   25 
Region of Enrollment 
[Units: Participants]
 
United States   25 


  Outcome Measures
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1.  Primary:   PSA Response   [ Time Frame: Up to 6 years ]

2.  Secondary:   Time to Progression   [ Time Frame: From the date of registration to the date of documented PSA progression, assessed up to 6 years ]


  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
Study was terminated early after the first stage of a two-stage design, allowing for early termination for discouraging results.


  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: DCC Project Administrator
Organization: California Cancer Consortium
phone: 626-256-4673 ext 60094
e-mail: CCCP@coh.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00058214     History of Changes
Other Study ID Numbers: NCI-2012-02832
PHII-44
N01CM17101 ( US NIH Grant/Contract Award Number )
CDR0000287195 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: April 7, 2003
Results First Received: February 9, 2015
Last Updated: February 9, 2015
Health Authority: United States: Food and Drug Administration