Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003614
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2000-11-06
Brief Title:
Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Study of Weekly Paclitaxel by 1-HR Infusion Plus Estramustine in Metastatic Hormone-Refractory Prostate Carcinoma
Status:
COMPLETED
Status Verified Date:
2023-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one 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 effect of weekly paclitaxel plus estramustine on PSA response in patients with metastatic hormone-refractory prostate cancer II Describe the toxic effects of this treatment in this patient population III Determine the effect of treatment on pain asthenia and quality of life IV Determine the objective response rate after treatment among the patients with bidimensionally measurable disease
OUTLINE Patients receive estramustine orally twice a day on days 1-3 of each week for 6 weeks Patients also receive paclitaxel IV over 1 hour on day 2 of each week for 6 weeks Courses repeat every 8 weeks in the absence of unacceptable toxicity and disease progression Quality of life is assessed prior to treatment and at weeks 4 8 20 and 24 Patients are followed every 3 months for 2 years every 6 months for years 2-5 and then annually thereafter
PROJECTED ACCRUAL There will be 17-52 patients accrued into this study over 14 months
OUTLINE Patients receive estramustine orally twice a day on days 1-3 of each week for 6 weeks Patients also receive paclitaxel IV over 1 hour on day 2 of each week for 6 weeks Courses repeat every 8 weeks in the absence of unacceptable toxicity and disease progression Quality of life is assessed prior to treatment and at weeks 4 8 20 and 24 Patients are followed every 3 months for 2 years every 6 months for years 2-5 and then annually thereafter
PROJECTED ACCRUAL There will be 17-52 patients accrued into this study over 14 months
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 |
|---|---|---|---|
| E-1898 | None | None | None |