NCT00384839

Vidaza to Restore Hormone Thx Prostate

Phase II Study for the Use of Vidaza™ to Restore Responsiveness of Patients' Prostate Cancers to Hormonal Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: US Oncology Research · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-04-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2006-10-06
• Last updated: 2018-10-25
• Results posted: 2018-10-25

Locations

13 sites across 1 country: United States