Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041067
Status:
COMPLETED
Last Update Posted:
2013-06-06
First Post:
2002-07-08
Brief Title:
S0215 Trastuzumab 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 NSC-628503 And Vinorelbine NSC-608210 Plus Filgrastim NSC-614629 With Weekly Trastuzumab NSC-688097 For HER-2 Positive Stage IV Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-05
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 work in different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Colony-stimulating factors such as filgrastim may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase II trial to study the effectiveness of combining trastuzumab with docetaxel vinorelbine and filgrastim in treating women who have stage IV breast cancer
PURPOSE Phase II trial to study the effectiveness of combining trastuzumab with docetaxel vinorelbine and filgrastim in treating women who have stage IV breast cancer
Detailed Description:
OBJECTIVES
Determine the 1-year survival of women with HER2-positive stage IV breast cancer treated with trastuzumab Herceptin docetaxel and vinorelbine with filgrastim G-CSF support
Determine the response rate complete and partial confirmed and unconfirmed in the subset of patients with measurable disease treated with this regimen
Determine the progression-free survival of patients treated with this regimen
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Obtain tissue blocks for the determination of predictors of response eg beta-tubulin mutations to microtubule interacting agents in this patient population and for other future studies
OUTLINE This is a pilot multicenter study
Patients receive docetaxel IV over 1 hour on day 1 filgrastim G-CSF subcutaneously on days 2-21 vinorelbine IV over 6-10 minutes on days 8 and 15 and trastuzumab Herceptin IV over 30-90 minutes on days 1 8 and 15 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity If docetaxel and vinorelbine are discontinued due to unacceptable toxicity patients may continue to receive trastuzumab If trastuzumab is discontinued due to unacceptable toxicity patients may continue to receive chemotherapy with G-CSF support
Patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study within 18-225 months
Determine the 1-year survival of women with HER2-positive stage IV breast cancer treated with trastuzumab Herceptin docetaxel and vinorelbine with filgrastim G-CSF support
Determine the response rate complete and partial confirmed and unconfirmed in the subset of patients with measurable disease treated with this regimen
Determine the progression-free survival of patients treated with this regimen
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Obtain tissue blocks for the determination of predictors of response eg beta-tubulin mutations to microtubule interacting agents in this patient population and for other future studies
OUTLINE This is a pilot multicenter study
Patients receive docetaxel IV over 1 hour on day 1 filgrastim G-CSF subcutaneously on days 2-21 vinorelbine IV over 6-10 minutes on days 8 and 15 and trastuzumab Herceptin IV over 30-90 minutes on days 1 8 and 15 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity If docetaxel and vinorelbine are discontinued due to unacceptable toxicity patients may continue to receive trastuzumab If trastuzumab is discontinued due to unacceptable toxicity patients may continue to receive chemotherapy with G-CSF support
Patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study within 18-225 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 |
| S0215 | OTHER | None | None |