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Phase II Study for the Use of Vidaza™ to Restore Responsiveness of Patients' Prostate Cancers to Hormonal Therapy

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Phase II Study for the Use of Vidaza™ to Restore Responsiveness of Patients' Prostate Cancers to Hormonal Therapy

This is an open label Phase II study. Patients will receive Vidaza for 5 consecutive days
(Days 1- 5) of each 28-day cycle. Complete androgen ablation will be continued. Response
will be assessed after a minimum of 2 cycles (evaluable patients). PSA response will be
evaluated prior to each cycle and % fetal hemoglobin will be evaluated prior to each odd
cycle (excluding Cycle 1). Patients will be treated until clinical progression up to a
maximum of 12 cycles. A total of 35 patients with advanced metastatic HRPC will be enrolled
in this trial.

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 (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

- Has signed a Patient Informed Consent Form

- Has signed a Patient Authorization Form


- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine if Vidaza can convert hormone-refractory prostate cancer to a hormone-responsive state

Outcome Time Frame:

Patients will be treated until clinical progression up to a maximum of 12 cycles

Safety Issue:


Principal Investigator

Guru Sonpavde, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology Research


United States: Institutional Review Board

Study ID:




Start Date:

April 2006

Completion Date:

November 2009

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



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