Vidaza to Restore Hormone Thx Prostate
Information source: US Oncology Research
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: azacitidine for injectable suspension (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: US Oncology Research Official(s) and/or principal investigator(s):
Guru Sonpavde, MD, Principal Investigator, Affiliation: US Oncology Research
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.
Clinical Details
Official title: Phase II Study for the Use of Vidaza™ to Restore Responsiveness of Patients' Prostate Cancers to Hormonal Therapy
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: To determine if Vidaza can convert hormone-refractory prostate cancer to a hormone-responsive state
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Rocky Mountain Cancer Center-Midtown, Denver, Colorado 80218, United States
Cancer Centers of Florida, P.A., Ocoee, Florida 34761, United States
Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota 55404, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada 89109, United States
New York Oncology Hematology, P.C., Albany, New York 12208, United States
Raleigh Hematology Oncology Associates, Cary, North Carolina 27511, United States
Northwestern Carolina Oncology Hematology, Hickory, North Carolina 28602, United States
Texas Oncology, P.A., Dallas, Texas 75246, United States
Tyler Cancer Center, Tyler, Texas 75702, United States
Texas Oncology, P.A., Fort Worth, Texas 76104, United States
Deke Slayton Cancer Center, Webster, Texas 77598, United States
Virginia Oncology Associates, Norfolk, Virginia 23502, United States
Cancer Care Nrothwest-South, Spokane, Washington 99202, United States
Additional Information
Starting date: April 2006
Ending date: December 2009
Last updated: April 22, 2008
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