Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024414
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2001-09-13
Brief Title:
DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer
Sponsor:
Theradex
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Open-Label Study of Taxoprexin DHA-Paclitaxel Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Hormone-Refractory Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2003-03
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
PURPOSE Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES
Determine the objective tumor response rate or prostate-specific antigen response duration of response and time to disease progression in patients with metastatic hormone-refractory prostate cancer treated with DHA-paclitaxel
Determine the overall survival of patients treated with this drug
Determine the toxicity profile of this drug in these patients
Assess the quality of life of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive DHA-paclitaxel IV over 2 hours on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 2 courses and off study
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 18-50 patients will be accrued for this study
Determine the objective tumor response rate or prostate-specific antigen response duration of response and time to disease progression in patients with metastatic hormone-refractory prostate cancer treated with DHA-paclitaxel
Determine the overall survival of patients treated with this drug
Determine the toxicity profile of this drug in these patients
Assess the quality of life of patients treated with this drug
OUTLINE This is a multicenter study
Patients receive DHA-paclitaxel IV over 2 hours on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 2 courses and off study
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 18-50 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PROTARGA-P01-00-04 | None | None | None |
| THERADEX-P01-00-04 | None | None | None |
| JHOC-01011003 | None | None | None |