Vidaza to Restore Hormone Thx Prostate
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: azacitidine for injectable suspension
Intervention description: Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.
Intervention MeSH terms: Azacitidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to find out what effects (good and bad) Vidaza has on
      patients with prostate cancer. This investigational drug is not approved by the Food and Drug
      Administration (FDA) for the treatment of prostate cancer; however, it is approved in
      myelodysplastic syndrome - a bone marrow disease. The pharmaceutical company involved in this
      study, Pharmion Corporation, is the manufacturer of Vidaza.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  A diagnosis of histologically confirmed, progressive, advanced metastatic, or
             nonmetastatic prostate cancer with documented PSA progression, with a calculated PSA
             doubling time <3 months, on complete androgen ablation therapy. PSA progression, with
             or without clinical progression (symptomatic/radiologic as per RECIST) is required;
             measurable disease is not required.

        Baseline PSA values must be followed by 2 serial increases at least 2 weeks apart (no upper
        limit for time for these 2 samples). Calculated PSA doubling time, for the above PSA values
        must be <3 months. An automated PSA doubling time calculator may be found at
        www.mskcc.org/mskcc/html/10088.cfm (see study tools).

          -  Currently on complete androgen ablation hormone therapy (an LHRH agonist plus an
             antiandrogen) with testosterone level <50ng/dL). Patients who are on LHRH agonist or
             other antiandrogenic therapy at entry will continue that therapy while on this study.
             Anti-androgen withdrawal is not necessary and is precluded before enrollment on the
             trial. The details of that therapy must be recorded in the CRF. Patients who have had
             an orchiectomy and who are on antiandrogen therapy are permitted on study.

          -  An elevated PSA level for patients progressing by PSA criteria is required (see
             protocol for specific detail).

          -  Has a Karnofsky Performance Status >70

          -  Is greater than 18 years of age

          -  Must meet specific lab values for the following criteria: granulocyte, platelet count,
             total bilirubin, AST and ALT, serum creatinine, calculated creatinine clearance &
             urinalysis (see protocol for specific detail).

          -  If fertile, the patient has agreed to use an acceptable method of birth control to
             avoid fathering a child for the duration of the study and for a period of 2 months
             thereafter.

          -  Has signed a Patient Informed Consent Form

          -  Has signed a Patient Authorization Form

        EXCLUSION CRITERIA:

          -  Has only clinical progression without evidence of PSA progression

          -  Has received prior chemotherapy

          -  Has had prior treatment with Vidaza

          -  Has a history of hypersensitivity to any component of Vidaza (mannitol)

          -  Has a history of New York Heart Association (NYHA) heart disease Class III or IV
             (Appendix III) or myocardial infarction within 6 months prior to Day 1 or unstable
             arrhythmia or evidence of ischemia on electrocardiogram (ECG)

          -  Is receiving concurrent immunotherapy

          -  Is receiving concurrent bisphosphonate therapy; long-standing bisphosphonate therapy
             (initiated >8 weeks prior to registration) is acceptable. Bisphosphonates started
             within the prior 8 weeks will not be allowed since this may affect other study
             endpoints and render their interpretation difficult.

          -  Has received treatment with radiation therapy, surgery, chemotherapy, ketoconazole,
             corticosteroids, or an investigational agent within 1 month prior to registration, (6
             weeks for radiation therapy, nitrosureas or Mitomycin C)

          -  Has evidence of central nervous system (CNS) involvement

          -  Has a serious uncontrolled intercurrent medical or psychiatric illness, including
             serious infection that requires systemic therapy

          -  Has a serious uncontrolled nonmalignant disease (liver failure, or other condition)
             that could compromise protocol objectives in the opinion of the Investigator

          -  Has a history of other malignancy within the last 5 years (except cured basal cell
             carcinoma of skin), which could affect the diagnosis or assessment of any of the study
             drugs

          -  Is known to be positive for the human immunodeficiency virus (HIV), hepatitis B, or
             hepatitis C

          -  Is unable to comply with requirements of study