Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084565
Status:
WITHDRAWN
Last Update Posted:
2013-07-10
First Post:
2004-06-10
Brief Title:
Paclitaxel Topotecan and Estramustine in Treating Patients With Metastatic Hormone-Refractory Prostate Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase II Study of the Activity of Weekly Paclitaxel Topotecan Plus Oral Estramustine Phosphate in Metastatic Hormone-Refractory Prostate Carcinoma
Status:
WITHDRAWN
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was never activated at Fox Chase Cancer Center
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 such as paclitaxel topotecan and estramustine work in different ways to stop tumor cells from dividing so they stop growing or die Giving more than one chemotherapy drug may kill more tumor cells
PURPOSE This phase II trial is studying how well giving paclitaxel topotecan and estramustine together works in treating patients with metastatic hormone therapy-refractory prostate cancer
PURPOSE This phase II trial is studying how well giving paclitaxel topotecan and estramustine together works in treating patients with metastatic hormone therapy-refractory prostate cancer
Detailed Description:
OBJECTIVES
Primary
Determine the objective response rate in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel topotecan and estramustine
Determine the progression-free and overall survival of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Secondary
Determine the frequency and number of circulating tumor cells in patients before and after treatment with this regimen and at disease progression
Determine the microtubule morphology β-tubulin isotype pattern apoptotic markers and metaphase chromosome alignment in circulating tumor cells in patients before and after treatment with this regimen and at disease progression
OUTLINE Patients receive paclitaxel IV over 1 hour on days 1 8 and 15 topotecan IV over 30 minutes on days 2 9 and 16 and oral estramustine twice daily on days 1 and 2 of course 1 and on days 0-2 7-9 and 14-16 of all subsequent courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 18-38 patients will be accrued for this study
Primary
Determine the objective response rate in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel topotecan and estramustine
Determine the progression-free and overall survival of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Secondary
Determine the frequency and number of circulating tumor cells in patients before and after treatment with this regimen and at disease progression
Determine the microtubule morphology β-tubulin isotype pattern apoptotic markers and metaphase chromosome alignment in circulating tumor cells in patients before and after treatment with this regimen and at disease progression
OUTLINE Patients receive paclitaxel IV over 1 hour on days 1 8 and 15 topotecan IV over 30 minutes on days 2 9 and 16 and oral estramustine twice daily on days 1 and 2 of course 1 and on days 0-2 7-9 and 14-16 of all subsequent courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 18-38 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 |
|---|---|---|---|
| CDR0000365459 | REGISTRY | PDQ Physician Data Query | None |