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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine if Vidaza can convert hormone-refractory prostate cancer to a hormone-responsive state
Patients will be treated until clinical progression up to a maximum of 12 cycles
No
Guru Sonpavde, MD
Principal Investigator
US Oncology Research
United States: Institutional Review Board
05015
NCT00384839
April 2006
November 2009
Name | Location |
---|---|
Texas Oncology, P.A. | Dallas, Texas 75246 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
Tyler Cancer Center | Tyler, Texas 75702 |
New York Oncology Hematology, P.C. | Albany, New York 12208 |
Cancer Centers of Florida, P.A. | Orlando, Florida |
Rocky Mountain Cancer Center-Midtown | Denver, Colorado 80218 |
Minnesota Oncology Hematology, P.A. | Minneapolis, Minnesota 55407 |
Raleigh Hematology Oncology Associates | Cary, North Carolina 27511 |
Deke Slayton Cancer Center | Webster, Texas 77589 |
Northwestern Carolina Oncology Hematology | Hickory, North Carolina 28602 |
Cancer Care Nrothwest-South | Spokane, Washington 99202 |