Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052845
Status:
COMPLETED
Last Update Posted:
2016-07-01
First Post:
2003-01-24
Brief Title:
Docetaxel Estramustine and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study Of Estramustine Docetaxel And Exisulind IND 64733 In Men With Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2016-06
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:
RATIONALE Androgens can stimulate the growth of prostate cancer cells Estramustine may fight prostate cancer by reducing the production of androgens Exisulind may stop the growth of prostate cancer by stopping blood flow to the tumor Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining these therapies may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining estramustine with exisulind and docetaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of combining estramustine with exisulind and docetaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES
Determine the time to objective and biochemical progression and response proportion objective and post-therapy changes in PSA in patients with hormone refractory metastatic prostate cancer treated with docetaxel estramustine and exisulind
Determine the toxic effects of this regimen in these patients
Determine the overall survival of patients treated with this regimen
OUTLINE Patients receive oral estramustine 3 times daily on days 1-5 docetaxel IV over 1 hour on day 2 and oral exisulind twice daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years
Determine the time to objective and biochemical progression and response proportion objective and post-therapy changes in PSA in patients with hormone refractory metastatic prostate cancer treated with docetaxel estramustine and exisulind
Determine the toxic effects of this regimen in these patients
Determine the overall survival of patients treated with this regimen
OUTLINE Patients receive oral estramustine 3 times daily on days 1-5 docetaxel IV over 1 hour on day 2 and oral exisulind twice daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000258766 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-90004 | None | None | None |