Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075465
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2004-01-09
Brief Title:
Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach
Status:
UNKNOWN
Status Verified Date:
2007-07
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 such as docetaxel and epirubicin work in different ways to stop tumor cells from dividing so they stop growing or die Giving more than one drug may kill more tumor cells
PURPOSE This phase II trial is studying how well giving docetaxel together with epirubicin as first-line therapy works in treating patients with locally advanced or metastatic adenocarcinoma cancer of the stomach
PURPOSE This phase II trial is studying how well giving docetaxel together with epirubicin as first-line therapy works in treating patients with locally advanced or metastatic adenocarcinoma cancer of the stomach
Detailed Description:
OBJECTIVES
Primary
Determine the objective tumor response rate and time to tumor progression in patients with locally advanced or metastatic adenocarcinoma of the stomach treated with docetaxel and epirubicin as first-line therapy
Secondary
Determine the survival without local relapse and overall survival of patients treated with this regimen
Determine the tolerance to this regimen in these patients
OUTLINE This is an open-label multicenter study
Patients receive epirubicin IV over 30 minutes and docetaxel IV over 1 hour on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 39 patients will be accrued for this study
Primary
Determine the objective tumor response rate and time to tumor progression in patients with locally advanced or metastatic adenocarcinoma of the stomach treated with docetaxel and epirubicin as first-line therapy
Secondary
Determine the survival without local relapse and overall survival of patients treated with this regimen
Determine the tolerance to this regimen in these patients
OUTLINE This is an open-label multicenter study
Patients receive epirubicin IV over 30 minutes and docetaxel IV over 1 hour on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 39 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 |
|---|---|---|---|
| FRE-GERCOR-EPITAXD00-1 | None | None | None |
| EU-20326 | None | None | None |