Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026078
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2001-11-09
Brief Title:
Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer
Sponsor:
Grupo Oncologico Cooperativo del Sur
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Docetaxel DTX - Ifosfamide IFX As First Line Chemotherapy In Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2006-11
Last Known Status:
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 docetaxel and ifosfamide in treating women who have metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of docetaxel and ifosfamide in treating women who have metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of docetaxel and ifosfamide as first-line chemotherapy in women with metastatic breast cancer
Determine the response rate and duration of response of patients treated with this regimen
Determine the time to treatment failure and survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour on day 1 and ifosfamide IV over 1 hour beginning 1 hour after docetaxel infusion on days 1-3 Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every month during study and then every 3 months after completion of study
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 15-42 patients will be accrued for this study
Determine the efficacy of docetaxel and ifosfamide as first-line chemotherapy in women with metastatic breast cancer
Determine the response rate and duration of response of patients treated with this regimen
Determine the time to treatment failure and survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour on day 1 and ifosfamide IV over 1 hour beginning 1 hour after docetaxel infusion on days 1-3 Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every month during study and then every 3 months after completion of study
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 15-42 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 |
|---|---|---|---|
| NCI-V01-1670 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068969 | REGISTRY | None | None |