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Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel

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ClinicalTrials.gov Identifier: NCT01253642
Recruitment Status : Terminated (low enrollment)
First Posted : December 3, 2010
Results First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The Wayne D. Kuni and Joan E. Kuni Foundation
Information provided by (Responsible Party):
Tom Beer, OHSU Knight Cancer Institute

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hormone-Resistant Prostate Cancer
Metastatic Prostatic Adenocarcinoma
Prostate Adenocarcinoma
Recurrent Prostate Carcinoma
Interventions: Procedure: Biopsy of Prostate
Drug: Docetaxel
Other: Laboratory Biomarker Analysis
Drug: Phenelzine Sulfate

  Participant Flow

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
Combination Phenelzine and Docetaxel Patients receive phenelzine sulfate orally (PO) once daily (QD) on days -7 to -4, and then twice daily (BID) on days -3 to 21. Patients receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Combination Phenelzine and Docetaxel
STARTED   11 
COMPLETED   6 
NOT COMPLETED   5 



  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.
11 subjects received combination therapy

Reporting Groups
  Description
Combination Phenelzine and Docetaxel Patients receive phenelzine sulfate PO QD on days -7 to -4, and then BID on days -3 to 21. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.

Baseline Measures
   Combination Phenelzine and Docetaxel 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Years]
Median (Full Range)
 68 
 (60 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      11 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      11 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      11 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   11 


  Outcome Measures

1.  Primary:   Proportion of Patients Who Experience a PSA (Prostate-Specific Antigen) Decline of at Least 30%   [ Time Frame: Within 12 weeks ]

2.  Secondary:   Duration of Progression Free Survival After Initiation of Combination Phenelzine and Docetaxel Therapy   [ Time Frame: Up to 6 years ]

3.  Secondary:   Frequency of MAOA (Monoamine Oxidase A) Overexpression in CRPC (Castration-Resistant Prostate Cancer) Tumors That Are Progressing on Docetaxel   [ Time Frame: Baseline ]

4.  Secondary:   HIF-1alpha Expression in CTC (Circulating Tumor Cells) as a Potential Measure of MAO Activity   [ Time Frame: Up to 6 years ]

5.  Secondary:   MAOA Expression in CTC (Circulating Tumor Cells) and Comparison to Biopsy MAOA Expression   [ Time Frame: Up to 6 years ]

6.  Secondary:   Maximum Change in PSA   [ Time Frame: 12 weeks (or earlier in patients who discontinued early) ]

7.  Secondary:   Response Rate in Measurable Disease by RECIST (Response Evaluation Criteria In Solid Tumors) Criteria   [ Time Frame: Up to 6 years ]

8.  Secondary:   Time to Death From All Causes   [ Time Frame: Up to 6 years ]

9.  Secondary:   Toxicity of the Regimen   [ Time Frame: Up to 6 years ]

10.  Other Pre-specified:   Frequency of Gene Expression   [ Time Frame: Up to 6 years ]
Results not yet reported.   Anticipated Reporting Date:   03/2019  

11.  Other Pre-specified:   Frequency of LSD-1 (Lysine-specific Histone Demethylase 1) Expression   [ Time Frame: Up to 6 years ]
Results not yet reported.   Anticipated Reporting Date:   03/2019  


  Serious Adverse Events


  Other Adverse Events


  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
Early termination leading to small numbers of subjects analyzed; overall morbidity of patient population prohibited long term treatment or follow-up.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kristi Eilers
Organization: OHSU Knight Cancer Institute
phone: 503-494-2897
e-mail: eilersk@ohsu.edu



Responsible Party: Tom Beer, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01253642     History of Changes
Other Study ID Numbers: IRB00005688
NCI-2010-02037 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SOL-09105-LM
5688
OHSU-5688
e5688
MR00045508
MR46390
IRB00005688 ( Other Identifier: OHSU Knight Cancer Institute )
P30CA069533 ( U.S. NIH Grant/Contract )
First Submitted: November 15, 2010
First Posted: December 3, 2010
Results First Submitted: September 14, 2017
Results First Posted: December 11, 2017
Last Update Posted: December 11, 2017