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Sponsors and Collaborators: |
US Oncology Research Celgene Corporation Norris Comprehensive Cancer Center |
Information provided by: | US Oncology Research |
ClinicalTrials.gov Identifier: | NCT00384839 |
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.
Condition | Intervention | Phase |
Prostate Cancer |
Drug: azacitidine for injectable suspension |
Phase II |
MedlinePlus related topics: | Cancer Prostate Cancer |
Drug Information available for: | Azacitidine |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study for the Use of Vidaza™ to Restore Responsiveness of Patients' Prostate Cancers to Hormonal Therapy |
Estimated Enrollment: | 36 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: azacitidine for injectable suspension
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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
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).
EXCLUSION CRITERIA:
United States, Colorado | |||||
Rocky Mountain Cancer Center-Midtown | |||||
Denver, Colorado, United States, 80218 | |||||
United States, Florida | |||||
Cancer Centers of Florida, P.A. | |||||
Ocoee, Florida, United States, 34761 | |||||
United States, Minnesota | |||||
Minnesota Oncology Hematology, P.A. | |||||
Minneapolis, Minnesota, United States, 55404 | |||||
United States, Nevada | |||||
Comprehensive Cancer Centers of Nevada | |||||
Las Vegas, Nevada, United States, 89109 | |||||
United States, New York | |||||
New York Oncology Hematology, P.C. | |||||
Albany, New York, United States, 12208 | |||||
United States, North Carolina | |||||
Raleigh Hematology Oncology Associates | |||||
Cary, North Carolina, United States, 27511 | |||||
Northwestern Carolina Oncology Hematology | |||||
Hickory, North Carolina, United States, 28602 | |||||
United States, Texas | |||||
Texas Oncology, P.A. | |||||
Dallas, Texas, United States, 75246 | |||||
Tyler Cancer Center | |||||
Tyler, Texas, United States, 75702 | |||||
Texas Oncology, P.A. | |||||
Fort Worth, Texas, United States, 76104 | |||||
Deke Slayton Cancer Center | |||||
Webster, Texas, United States, 77598 | |||||
United States, Virginia | |||||
Virginia Oncology Associates | |||||
Norfolk, Virginia, United States, 23502 | |||||
United States, Washington | |||||
Cancer Care Nrothwest-South | |||||
Spokane, Washington, United States, 99202 |
US Oncology Research |
Celgene Corporation |
Norris Comprehensive Cancer Center |
Principal Investigator: | Guru Sonpavde, MD | US Oncology Research |
Responsible Party: | US Oncology Research ( Angelica McCallister ) |
Study ID Numbers: | 05015 |
First Received: | October 4, 2006 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00384839 |
Health Authority: | United States: Institutional Review Board |
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