Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001239
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Combination Chemotherapy FLAC Combined With Granulocyte-Macrophage Colony Stimulating Factor in Locally Advanced and Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Combination Chemotherapy FLAC Combined With Granulocyte-Macrophage Colony Stimulating Factor in Locally Advanced and Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2000-04
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:
To evaluate a dose intensive chemotherapy regimen for the treatment of locally advanced and metastatic breast cancer using granulocyte-macrophage colony-stimulating factor GM-CSF to ameliorate chemotherapy-induced toxicity Combination chemotherapy consists of Flurouricil Leucovorin Adriamycin and Cytoxan FLAC which will be given every 21 days for 10 cycles This protocol will replace the phase I study of this regimen MB-23288-C-0207 which found the MTD of this regimen to be at the first dose level This is a phase II study to determine response rates of this regimen in advanced breast cancer
Detailed Description:
To evaluate a dose intensive chemotherapy regimen for the treatment of locally advanced and metastatic breast cancer using granulocyte-macrophage colony-stimulating factor GM-CSF to ameliorate chemotherapy-induced toxicity Combination chemotherapy consists of Flurouricil Leucovorin Adriamycin and Cytoxan FLAC which will be given every 21 days for 10 cycles This protocol will replace the phase I study of this regimen MB-23288-C-0207 which found the MTD of this regimen to be at the first dose level This is a phase II study to determine response rates of this regimen in advanced breast cancer
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 |
|---|---|---|---|
| 89-C-0119 | None | None | None |