Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006682
Status:
COMPLETED
Last Update Posted:
2020-08-14
First Post:
2000-12-06
Brief Title:
Vinorelbine and Docetaxel in Treating Women With Metastatic Breast Cancer
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
An Open-Label Phase II Study of Navelbine Vinorelbine Tartrate and Taxotere Docetaxel as First-Line Therapy for Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2001-05
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 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 vinorelbine combined with docetaxel in treating women who have metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of vinorelbine combined with docetaxel in treating women who have metastatic breast cancer
Detailed Description:
OBJECTIVES I Determine the response rate in women with metastatic breast cancer treated with vinorelbine and docetaxel II Determine the time to disease progression time to treatment failure response duration and survival in this patient population treated with this regimen
OUTLINE This is a multicenter study Patients receive vinorelbine IV on days 1 and 8 and docetaxel IV over 1 hour on day 1 only Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed for 1 month and then every 15-3 months for 1 year
PROJECTED ACCRUAL Approximately 69 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive vinorelbine IV on days 1 and 8 and docetaxel IV over 1 hour on day 1 only Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity Patients are followed for 1 month and then every 15-3 months for 1 year
PROJECTED ACCRUAL Approximately 69 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 |
|---|---|---|---|
| NCI-V00-1631 | None | None | None |
| WHC-2000056 | None | None | None |