Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024401
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2001-09-13
Brief Title:
DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Theradex
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Open-Label Study of Taxoperxin DHA-Paclitacel Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Cancer of the ColonRectum
Status:
UNKNOWN
Status Verified Date:
2002-06
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 colorectal cancer
PURPOSE Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Determine the objective tumor response rate duration of response and time to disease progression in patients with metastatic colorectal cancer treated with DHA-paclitaxel II Determine the overall survival of patients treated with this drug III Determine the toxicity profile of this drug in these patients IV 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 end of study treatment Patients are followed every 3 months
PROJECTED ACCRUAL A total of 18-50 patients will be accrued for this study
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 end of study treatment 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:
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 |
|---|---|---|---|
| PROTARGA-P01-00-01 | None | None | None |
| THERADEX-P01-00-01 | None | None | None |
| ABCCC-010505 | None | None | None |