Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006121
Status:
TERMINATED
Last Update Posted:
2012-07-24
First Post:
2000-08-03
Brief Title:
Oxaliplatin in Treating Women With Advanced or Metastatic Breast Cancer That Has Not Responded to Previous Chemotherapy
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of AnthracyclineTaxane Based Chemotherapy
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 oxaliplatin in treating women who have advanced or metastatic breast cancer that has not responded to previous chemotherapy
PURPOSE Phase II trial to study the effectiveness of oxaliplatin in treating women who have advanced or metastatic breast cancer that has not responded to previous chemotherapy
Detailed Description:
OBJECTIVES
Determine the therapeutic activity of oxaliplatin in patients with advanced or metastatic breast cancer following failure of anthracyclinetaxane based chemotherapy
Determine objective response duration of response and time to progression in these patients when treated with this regimen
Determine the acute side effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oxaliplatin IV over 2 hours on day 1 Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 weeks until disease progression and then every 3 months for survival
PROJECTED ACCRUAL A total of 27-40 patients will be accrued for this study
Determine the therapeutic activity of oxaliplatin in patients with advanced or metastatic breast cancer following failure of anthracyclinetaxane based chemotherapy
Determine objective response duration of response and time to progression in these patients when treated with this regimen
Determine the acute side effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oxaliplatin IV over 2 hours on day 1 Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 weeks until disease progression and then every 3 months for survival
PROJECTED ACCRUAL A total of 27-40 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 |
|---|---|---|---|
| EORTC-16001 | None | None | None |