Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003066
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
1999-11-01
Brief Title:
Docetaxel Combined With Estramustine in Treating Women With Metastatic Breast Cancer
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Evaluation of Docetaxel Combined With Estramustine Phosphate in Patients With Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2006-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 docetaxel combined with estramustine in treating women with metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of docetaxel combined with estramustine in treating women with metastatic breast cancer
Detailed Description:
OBJECTIVES I Determine the response rate duration of response duration of survival and quality of life effects of docetaxel and estramustine combination in women with metastatic breast cancer
OUTLINE Patients receive estramustine 3 times a day for 3 days Docetaxel begins on day 3 after the am dose of estramustine and is given as a 1 hour infusion intravenously Courses repeat every 21 days If disease responds or is stable treatment continues at the highest tolerance percentage of prescribed dose until appearance of disease progression If complete response is documented an additional 2 courses are given Patients should receive a minimum of 2 courses unless rapid progression or unacceptable toxicity occur Patients are followed monthly
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study
OUTLINE Patients receive estramustine 3 times a day for 3 days Docetaxel begins on day 3 after the am dose of estramustine and is given as a 1 hour infusion intravenously Courses repeat every 21 days If disease responds or is stable treatment continues at the highest tolerance percentage of prescribed dose until appearance of disease progression If complete response is documented an additional 2 courses are given Patients should receive a minimum of 2 courses unless rapid progression or unacceptable toxicity occur Patients are followed monthly
PROJECTED ACCRUAL Approximately 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 |
|---|---|---|---|
| NCI-V97-1325 | None | None | None |
| CPMC-IRB-7929 | None | None | None |