Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel
Condition: Hormone-Resistant Prostate Cancer; Metastatic Prostatic Adenocarcinoma; Prostate Adenocarcinoma; Recurrent Prostate Carcinoma
MeSH terms: Prostatic Neoplasms; Adenocarcinoma
Intervention: Biopsy of Prostate; Docetaxel; Laboratory Biomarker Analysis; Phenelzine Sulfate
Intervention description: Undergo transrectal ultrasound (TRUS) guided prostate biopsy OR image-guided (CT or ultrasound) core bone or soft tissue biopsy; Given IV; Correlative studies; Given PO
Intervention MeSH terms: Docetaxel; Phenelzine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of adenocarcinoma of the prostate

          -  Radiographic evidence of regional or distant metastases with suspected tumor in an
             area that is safe to biopsy

          -  Willingness to undergo tumor biopsy

          -  Evidence of CRPC indicated by history of progression despite standard hormonal therapy
             (by PSA and/or imaging studies)

          -  Planned or recent initiation of standard docetaxel therapy; patients may be enrolled
             after receiving standard docetaxel therapy as long as the patient has not demonstrated
             evidence of progression for more than 45 days before enrollment ("late enrollers")

          -  For patients who have been on anti-androgen therapy and had evidence of response to
             the addition of an anti-androgen (i.e., PSA reduction), patients must have
             discontinued anti-androgen therapy for at least six weeks (4 weeks for flutamide)
             without current evidence of an anti-androgen withdrawal response

          -  Serum testosterone levels < 50 ng/dL (unless surgically castrate); patients must
             continue androgen deprivation with an luteinizing hormone releasing hormone (LHRH)
             agonist if they have not undergone orchiectomy

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2

          -  Has recovered from all therapy-related toxicity to =< grade 2 (except alopecia, anemia
             and any signs or symptoms of androgen deprivation therapy)

          -  Absolute neutrophil count >= 1500/uL

          -  Platelets >= 100,000

          -  Creatinine =< 1.5 times upper limit of normal (ULN)

          -  Bilirubin =< 1.5 times ULN (if total bilirubin elevated, but direct is within normal
             limits [WNL], patient is eligible)

          -  Alanine aminotransferase (ALT) =< 2.5 times ULN

          -  PSA > 2 ng/mL (at the time of enrollment or prior to initiation of docetaxel)

          -  Life expectancy > 3 months

          -  Signed informed consent

        Exclusion Criteria:

          -  Significant peripheral neuropathy defined as grade 2 or higher

          -  A second active malignancy except adequately treated non-melanoma skin cancer or other
             non-invasive or in situ neoplasm

          -  Significant active concurrent medical illness or infection precluding protocol
             treatment or survival

          -  Current uncontrolled hyperthyroidism

          -  Pheochromocytoma

          -  Carcinoid Syndrome

          -  Known or suspected brain metastases

          -  Treatment with radiotherapy within the past 4 weeks or radiopharmaceutical therapy
             (strontium, samarium) within the past 8 weeks

          -  Concurrent therapy with a Selective Serotonin Reuptake Inhibitor (SSRI), tricyclic
             antidepressant, or Monoamine Oxidase Inhibitor (MAOi); clinical judgment should be
             used in a decision to discontinue antidepressants; a minimum of a 1 week washout
             period is required for any tricyclic or related antidepressant, or any SSRI (2 weeks
             for paroxetine or sertraline, 5 weeks for fluoxetine); minimum 2 week washout for any
             MAOi

          -  Concurrent therapy with any excluded medications that cannot be safely discontinued
             prior to initiation of combination therapy; discontinuation prior to enrollment is not
             required, but discontinuation prior to combination therapy must be possible

          -  Caution should be exercised in patients who are regularly taking narcotic analgesics,
             particularly higher doses; the doses of narcotic analgesics may need to be reduced,
             patients may need to be monitored closely for drug interactions, and the risks and
             benefits of participation in the study should be considered; clinical judgment should
             be exercised to manage this potential drug interaction