ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Enrollment 11

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Combination Phenelzine and Docetaxel
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 11
Completed 6
Not Completed 5
Arm/Group Title Combination Phenelzine and Docetaxel
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
11 subjects received combination therapy
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants
68
(60 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
0
   0.0%
Male
11
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
11
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Proportion of Patients Who Experience a PSA (Prostate-Specific Antigen) Decline of at Least 30%
Hide Description PSA response: A ≥ 30% reduction from baseline within 12 weeks of initiation of therapy (confirmed on a second measurement at least 3 weeks later).
Time Frame Within 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Phenelzine and Docetaxel
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
2
  18.2%
2.Secondary Outcome
Title Duration of Progression Free Survival After Initiation of Combination Phenelzine and Docetaxel Therapy
Hide Description Progression free survival is calculated as the time from Day 1 of Combination therapy to first evidence of progression (by PSA, Measureable Disease, or Clinical Progression). For subjects who did not meet progression criteria, date of new therapy or date of death was used. Outcome is reported as mean.
Time Frame Up to 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 subject withdrew from the study before the first evidence of progression and is not included in this progression free survival analysis.
Arm/Group Title Combination Phenelzine and Docetaxel
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: days
77.9
(57 to 99)
3.Secondary Outcome
Title Frequency of MAOA (Monoamine Oxidase A) Overexpression in CRPC (Castration-Resistant Prostate Cancer) Tumors That Are Progressing on Docetaxel
Hide Description Reported as Number of participants with MAOA expression greater than 5%.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who had evaluable samples collected immediately prior to initiation of Combination Therapy. 3 subjects did not have evaluable samples and were not included in this analysis.
Arm/Group Title Combination Phenelzine and Docetaxel
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
8
 100.0%
4.Secondary Outcome
Title HIF-1alpha Expression in CTC (Circulating Tumor Cells) as a Potential Measure of MAO Activity
Hide Description [Not Specified]
Time Frame Up to 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of eleven subjects, CTC samples were collected from only 3. No testing was conducted on these 3 samples.
Arm/Group Title Combination Phenelzine and Docetaxel
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title MAOA Expression in CTC (Circulating Tumor Cells) and Comparison to Biopsy MAOA Expression
Hide Description A Pearson's correlation will be used to correlate tumor biopsy MAOA expression and circulating tumor cells MAOA expression.
Time Frame Up to 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of eleven subjects, CTC samples were collected from only 3. No testing was conducted on these 3 samples.
Arm/Group Title Combination Phenelzine and Docetaxel
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Maximum Change in PSA
Hide Description Measured from Day 1 of Combination therapy to PSA at 12 Weeks on therapy (or earlier if subject not on therapy for 12 weeks).
Time Frame 12 weeks (or earlier in patients who discontinued early)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 subject withdrew from the study before reaching 12 weeks and is not included in this progression free survival analysis.
Arm/Group Title Combination Phenelzine and Docetaxel
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: percentage of PSA change
14.24
(-46.56 to 69.94)
7.Secondary Outcome
Title Response Rate in Measurable Disease by RECIST (Response Evaluation Criteria In Solid Tumors) Criteria
Hide Description Response in measurable disease is defined as a 30% decrease in the sum of diameters of target lesions (as described by RECIST 1.1).
Time Frame Up to 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
3 subjects were excluded from this response rate calculation as they did not have additional scans beyond baseline.
Arm/Group Title Combination Phenelzine and Docetaxel
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
8.Secondary Outcome
Title Time to Death From All Causes
Hide Description Time to death is calculated from Day 1 of Combination therapy to death from any cause.
Time Frame Up to 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Phenelzine and Docetaxel
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Median (Full Range)
Unit of Measure: days
191.0
(99 to 621)
9.Secondary Outcome
Title Toxicity of the Regimen
Hide Description Number of participants who experienced an Adverse Event. Detail of Adverse Events is reported in the Adverse Event Section
Time Frame Up to 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination Phenelzine and Docetaxel
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
11
 100.0%
10.Other Pre-specified Outcome
Title Frequency of Gene Expression
Hide Description Outcome measure will be reported using descriptive statistics, after overall study completion (March 2019).
Time Frame Up to 6 years
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Frequency of LSD-1 (Lysine-specific Histone Demethylase 1) Expression
Hide Description Outcome measure will be reported using descriptive statistics, after overall study completion (March 2019).
Time Frame Up to 6 years
Outcome Measure Data Not Reported
Time Frame Adverse Events were collected from start of Combination Therapy (phenelzine and docetaxel) until off study for progression, adverse event, or other reason.
Adverse Event Reporting Description

Serious Adverse Events are considered Serious only if they are both unexpected and related to study. Hospitalizations that are expected for these study agents or the study population are not considered Serious Adverse Events.

Only Adverse Events that are considered possibly or definitely related to the study are reported.

 
Arm/Group Title Combination Phenelzine and Docetaxel
Hide Arm/Group Description 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.
All-Cause Mortality
Combination Phenelzine and Docetaxel
Affected / at Risk (%)
Total   11/11 (100.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Combination Phenelzine and Docetaxel
Affected / at Risk (%) # Events
Total   1/11 (9.09%)    
General disorders   
Sudden Death * 1  1/11 (9.09%)  11
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combination Phenelzine and Docetaxel
Affected / at Risk (%) # Events
Total   11/11 (100.00%)    
Blood and lymphatic system disorders   
Febrile Neutropenia * 1  2/11 (18.18%)  2
Anemia * 1  2/11 (18.18%)  2
Neutropenia * 1  1/11 (9.09%)  1
Eye disorders   
visual disturbance * 1  1/11 (9.09%)  1
Gastrointestinal disorders   
Constipation * 1  2/11 (18.18%)  2
Diarrhea * 1  3/11 (27.27%)  3
Nausea * 1  1/11 (9.09%)  1
Vomiting * 1  1/11 (9.09%)  1
Mucositis * 1  2/11 (18.18%)  2
General disorders   
Fatigue * 1  5/11 (45.45%)  5
Edema (bilateral extremity) * 1  1/11 (9.09%)  1
Irritability * 1  1/11 (9.09%)  1
Infections and infestations   
Sepsis * 1  1/11 (9.09%)  1
Thrush, oral * 1  1/11 (9.09%)  1
Investigations   
Weight gain * 1  2/11 (18.18%)  2
Metabolism and nutrition disorders   
Anorexia * 1  1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness * 1  2/11 (18.18%)  2
Pain, back * 1  1/11 (9.09%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cyst, neck * 1  1/11 (9.09%)  1
Nervous system disorders   
Dizziness * 1  2/11 (18.18%)  2
Syncope * 1  1/11 (9.09%)  1
Concentration Impairment * 1  1/11 (9.09%)  1
Sedation * 1  1/11 (9.09%)  1
Pre-syncope * 1  1/11 (9.09%)  1
Dysgeusia * 1  2/11 (18.18%)  2
Memory Loss * 1  1/11 (9.09%)  1
Neuropathy * 1  1/11 (9.09%)  1
Psychiatric disorders   
Anxiety * 1  2/11 (18.18%)  2
Confusion * 1  3/11 (27.27%)  3
Depression * 1  1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/11 (9.09%)  1
Dyspnea * 1  2/11 (18.18%)  2
Skin and subcutaneous tissue disorders   
Rash (torso) * 1  1/11 (9.09%)  1
Nail Changes * 1  2/11 (18.18%)  2
Dry skin * 1  2/11 (18.18%)  2
Alopecia * 1  1/11 (9.09%)  1
Vascular disorders   
Thromboembolic event * 1  1/11 (9.09%)  1
Hypertention * 1  3/11 (27.27%)  3
Orthostatic hypotension * 1  1/11 (9.09%)  1
Deep vein thrombosis * 1  1/11 (9.09%)  1
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Early termination leading to small numbers of subjects analyzed; overall morbidity of patient population prohibited long term treatment or follow-up.
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
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