Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003717
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
Sponsor:
St Barnabas Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Weekly Paclitaxel Plus Oral Estramustine in Patients With Hormone Refractory Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2001-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than once drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of paclitaxel plus estramustine in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of paclitaxel plus estramustine in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Determine the response rate PSA andor objective response and duration of response to weekly paclitaxel plus estramustine in patients with metastatic hormone refractory prostate cancer II Determine the effect on quality of life of this regimen in these patients
OUTLINE Patients receive paclitaxel IV over 1 hour weekly for 4 weeks Patients receive oral estramustine the day before the day of and the day after paclitaxel administration each week Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression A quality of life questionnaire is completed before treatment and 2 months after treatment initiation
PROJECTED ACCRUAL A total of 17 patients will be accrued for this study
OUTLINE Patients receive paclitaxel IV over 1 hour weekly for 4 weeks Patients receive oral estramustine the day before the day of and the day after paclitaxel administration each week Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression A quality of life questionnaire is completed before treatment and 2 months after treatment initiation
PROJECTED ACCRUAL A total of 17 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-V98-1509 | None | None | None |
| STBARN-IND-53879 | None | None | None |