Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134654
Status:
COMPLETED
Last Update Posted:
2011-06-16
First Post:
2005-08-24
Brief Title:
Two Doses of Conjugated Estrogen Premarin in Patients With Androgen-Independent Prostate Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Trial of Two Doses of Conjugated Estrogens Premarin in Patients With Androgen-Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2011-06
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 study is to see if Premarin is useful against androgen-independent prostate cancer and to help understand how drugs such as Premarin may work
Detailed Description:
Patients will be randomly assigned to one of two study groups arm A or Arm B Arm A will receive 125mg of Premarin once daily and arm B will receive 125mg of Premarin three times a day Patients will also receive coumadin daily to help prevent thromboembolic disease
After reviewing the first 30 patients on Arm A it was determined that arm A low dose Premarin was not effective Arm A was then closed and patients on Arm A were given the choice to switch to Arm B
Treatment will continue until there is evidence of disease progression or unacceptable side effects
Every 4 weeks while receiving Premarin a physical exam and blood work will be performed Every 12 weeks a CT scan of the abdomen and pelvis and a bone scan will be performed
Patients will also be encouraged to undergo standard preventative breast irradiation prior to starting Premarin or up to 4 weeks after starting treatment
After reviewing the first 30 patients on Arm A it was determined that arm A low dose Premarin was not effective Arm A was then closed and patients on Arm A were given the choice to switch to Arm B
Treatment will continue until there is evidence of disease progression or unacceptable side effects
Every 4 weeks while receiving Premarin a physical exam and blood work will be performed Every 12 weeks a CT scan of the abdomen and pelvis and a bone scan will be performed
Patients will also be encouraged to undergo standard preventative breast irradiation prior to starting Premarin or up to 4 weeks after starting treatment
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