Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384839
Status:
COMPLETED
Last Update Posted:
2018-10-25
First Post:
2006-10-04
Brief Title:
Vidaza to Restore Hormone Thx Prostate
Sponsor:
US Oncology Research
Organization:
US Oncology Research
Study Overview
Official Title:
Phase II Study for the Use of Vidaza to Restore Responsiveness of Patients Prostate Cancers to Hormonal Therapy
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None