Phase II Study for the Use of Vidaza™ to Restore Responsiveness of Patients' Prostate Cancers to Hormonal Therapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 12
- Primary Endpoint
- Percentage of Patients With PSA Doubling Time >=3 Months.
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
azacitidine for injectable suspension
Intervention: azacitidine for injectable suspension (Drug)
Outcomes
Primary Outcomes
Percentage of Patients With PSA Doubling Time >=3 Months.
Time Frame: Until progression or up to a maximum of 12 cycles
To determine if Vidaza can convert hormone-refractory prostate cancer to a hormone-responsive state. This will be assessed by the proportion of patients who have a documented prostate specific antigen (PSA) doubling time \>3= months.
Secondary Outcomes
- PSA Response Rate(Every 8 weeks for 1 year.)
- Objective Response Rate by Recist (ORR)(Every 8 weeks for 1 year.)
- Progression-free Survival(Up to 1.5 year.)
- 1-year Overall Survival (OS)(Up to 1 year.)
- Changes in Fetal Hemoglobin (HbF) With Time.(Up to 1 year.)