Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024375
Status:
UNKNOWN
Last Update Posted:
2009-02-18
First Post:
2001-09-13
Brief Title:
DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer
Sponsor:
Theradex
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Open-Label Study of Taxoperxin DHA-Paclitaxel Injection by 2 Hour Intravenous Infusion in Patients With Metastatic Cancer of the Pancreas
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 pancreatic cancer
PURPOSE Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic pancreatic cancer
Detailed Description:
OBJECTIVES
Determine the tumor response rate duration of response and time to disease progression in patients with metastatic carcinoma of the pancreas 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 at completion of treatment
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 21-50 patients will be accrued for this study
Determine the tumor response rate duration of response and time to disease progression in patients with metastatic carcinoma of the pancreas 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 at completion of treatment
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 21-50 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 |
|---|---|---|---|
| VMRC-8770 | None | None | None |
| THERADEX-P01-00-03 | None | None | None |
| PROTARGA-P01-00-03 | None | None | None |