Vidaza to Restore Hormone Thx Prostate

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
1	azacitidine for injectable suspension	azacitidine for injectable suspension

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With PSA Doubling Time >=3 Months.	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 Outcome Measures

Name	Time	Method
PSA Response Rate	Every 8 weeks for 1 year.	Complete PSA Response defined as complete normalization of PSA maintained for at least 4 weeks, and partial PSA response defined as a decrease in PSA level of at least 50% from baseline level maintained for at least 4 weeks.
Objective Response Rate by Recist (ORR)	Every 8 weeks for 1 year.	ORR = Complete Response (CR) + Parcial response (PR). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Progression-free Survival	Up to 1.5 year.	PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
1-year Overall Survival (OS)	Up to 1 year.	OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Changes in Fetal Hemoglobin (HbF) With Time.	Up to 1 year.	Time from baseline to maximal fetal hemoglobin (HbF).

Locations (12): Texas Oncology, P.A.
🇺🇸
Fort Worth, Texas, United States
Tyler Cancer Center
🇺🇸
Tyler, Texas, United States
Deke Slayton Cancer Center
🇺🇸
Webster, Texas, United States
Minnesota Oncology Hematology, P.A.
🇺🇸
Minneapolis, Minnesota, United States
New York Oncology Hematology, P.C.
🇺🇸
Albany, New York, United States
Northwestern Carolina Oncology Hematology
🇺🇸
Hickory, North Carolina, United States
Rocky Mountain Cancer Center-Midtown
🇺🇸
Denver, Colorado, United States
Cancer Centers of Florida, P.A.
🇺🇸
Ocoee, Florida, United States
Virginia Oncology Associates
🇺🇸
Norfolk, Virginia, United States
Cancer Care Nrothwest-South
🇺🇸
Spokane, Washington, United States
Raleigh Hematology Oncology Associates
🇺🇸
Cary, North Carolina, United States
Comprehensive Cancer Centers of Nevada
🇺🇸
Las Vegas, Nevada, United States