Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015886
Status:
COMPLETED
Last Update Posted:
2018-08-13
First Post:
2001-05-06
Brief Title:
Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Docetaxel Taxotere and 5-Fluorouracil As Second- Or Third-Line Chemotherapy In Women With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating women who have breast cancer that is metastatic or cannot be treated with surgery
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating women who have breast cancer that is metastatic or cannot be treated with surgery
Detailed Description:
OBJECTIVES
Determine the response rate in women with locally unresectable or metastatic breast cancer treated with docetaxel leucovorin calcium and fluorouracil as second or third-line chemotherapy
Evaluate the toxic effects of this regimen in these patients
Determine the time to progression in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour on day 1 and leucovorin calcium IV over 1 hour followed by fluorouracil IV over 5 minutes on days 1-3 Treatment repeats every 4 weeks for 2-8 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 21-45 patients will be accrued for this study within 44 months
Determine the response rate in women with locally unresectable or metastatic breast cancer treated with docetaxel leucovorin calcium and fluorouracil as second or third-line chemotherapy
Evaluate the toxic effects of this regimen in these patients
Determine the time to progression in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour on day 1 and leucovorin calcium IV over 1 hour followed by fluorouracil IV over 5 minutes on days 1-3 Treatment repeats every 4 weeks for 2-8 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 21-45 patients will be accrued for this study within 44 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NCI-3137 | None | None | None |
| CCCWFU-74896 | None | None | None |