Clinical Trials Directory

Trials / Terminated

TerminatedNCT01253642

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

A Phase II Study of MAOA Inhibitor Plus Docetaxel in Patients Receiving and Progressing on Docetaxel Therapy

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
11 (actual)
Sponsor
OHSU Knight Cancer Institute · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies how well giving phenelzine sulfate together with docetaxel works in treating patients with prostate cancer that is growing, spreading, or getting worse after first-line therapy with docetaxel. Phenelzine sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phenelzine sulfate may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving phenelzine sulfate together with docetaxel may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine the proportion of patients who experience a prostate specific antigen (PSA) decline of at least 30% within 12 weeks of initiation of combination therapy when phenelzine (phenelzine sulfate) is added to docetaxel in patients who have evidence of progression on standard docetaxel. SECONDARY OBJECTIVES: I. To determine duration of progression free survival after initiation of combination phenelzine and docetaxel therapy. II. To determine the response rate in measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria after initiation of combination phenelzine and docetaxel therapy. III. To report the maximum change in PSA from baseline to 12 weeks (or earlier in patients who discontinue early) by waterfall plot after initiation of combination phenelzine and docetaxel therapy. IV. To determine the toxicity of the combination regimen in castration-resistant prostate cancer (CRPC) previously treated with docetaxel. V. To determine time to death from all causes. VI. To determine the frequency of monoamine oxidase A (MAOA) overexpression in CRPC tumors that are progressing on docetaxel. VII. To compare the level of MAOA expression in primary diagnostic tissue (e.g. biopsy or radical prostatectomy) with CRPC tumors that are progressing on docetaxel. VIII. To correlate MAOA overexpression in CRPC tumors with response to combination study treatment. IX. To collect blood and tissue specimens for future molecular correlative studies. X. To validate MAOA assessment in circulating tumor cells. XI. To assess correlation with tissue expression of MAOA. XII. To measure hypoxia-inducible factor (HIF)-1alpha expression and other potential biomarkers in circulating tumor cells as a potential measure of MAO activity. TERTIARY OUTCOMES: I. To measure expression of lysine-specific histone demethylase 1 (LSD1) in CRPC tumors that are progressing on docetaxel and correlate with the endpoints described in the primary objective and secondary objectives I, II, III, and V. II. To conduct gene expression studies in CRPC tumors that are progressing on docetaxel and correlate them with and correlate with the endpoints described in the primary objective and secondary objectives I, II, III and V. OUTLINE: This is a dose-escalation study of phenelzine sulfate. 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. After completion of study treatment, patients are followed up every 6 months.

Conditions

Interventions

TypeNameDescription
PROCEDUREBiopsy of ProstateUndergo transrectal ultrasound (TRUS) guided prostate biopsy OR image-guided (CT or ultrasound) core bone or soft tissue biopsy
DRUGDocetaxelGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGPhenelzine SulfateGiven PO

Timeline

Start date
2010-07-12
Primary completion
2016-09-15
Completion
2017-09-15
First posted
2010-12-03
Last updated
2019-10-02
Results posted
2017-12-11

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01253642. Inclusion in this directory is not an endorsement.