Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015938
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2001-05-06
Brief Title:
S0102 Docetaxel Vinorelbine and Filgrastim in Treating Women With Stage IV Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Docetaxel And Vinorelbine Plus Filgrastim For HER-2 Negative Stage IV Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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 Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase II trial to study the effectiveness of combining docetaxel vinorelbine and filgrastim in treating women who have stage IV breast cancer
PURPOSE Phase II trial to study the effectiveness of combining docetaxel vinorelbine and filgrastim in treating women who have stage IV breast cancer
Detailed Description:
OBJECTIVES
Determine the 1-year survival of women with HER-2-negative stage IV breast cancer treated with docetaxel vinorelbine and filgrastim G-CSF
Determine the response rate both complete and partial response and time to progression in patients treated with this regimen
Determine the qualitative and quantitative toxic effects of this regimen in this patient population
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour on day 1 vinorelbine IV over 6-10 minutes on days 8 and 15 and filgrastim G-CSF subcutaneously on days 2-21 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study within 4-5 months
Determine the 1-year survival of women with HER-2-negative stage IV breast cancer treated with docetaxel vinorelbine and filgrastim G-CSF
Determine the response rate both complete and partial response and time to progression in patients treated with this regimen
Determine the qualitative and quantitative toxic effects of this regimen in this patient population
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour on day 1 vinorelbine IV over 6-10 minutes on days 8 and 15 and filgrastim G-CSF subcutaneously on days 2-21 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study within 4-5 months
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0102 | OTHER | None | None |