Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002866
Status:
COMPLETED
Last Update Posted:
2020-04-01
First Post:
1999-11-01
Brief Title:
Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Study of Docetaxel and Epirubicin as First-Line Therapy for Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-03
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 G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person s immune system recover from the side effects of chemotherapy
PURPOSE Phase III trial to study the effectiveness of docetaxel and epirubicin with and without G-CSF in treating women with metastatic breast cancer
PURPOSE Phase III trial to study the effectiveness of docetaxel and epirubicin with and without G-CSF in treating women with metastatic breast cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and recommended phase II dose of docetaxel in combination with epirubicin and filgrastim G-CSF as first-line therapy in women with metastatic breast cancer phase II closed as of 03272000 II Determine the pharmacokinetic profile of docetaxel and epirubicin in these patients III Evaluate the toxicity of this regimen given at the recommended phase II dose IV Determine the response rate and duration of response in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of epirubicin and docetaxel Patients receive epirubicin IV over 15 minutes followed by docetaxel IV over 60 minutes on day 1 Patients also receive filgrastim G-CSF subcutaneously on days 4-13 Treatment continues every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of epirubicin and docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose in which at least 2 of 6 patients experience dose-limiting toxicity Additional patients will be accrued to receive treatment at the recommended phase II dose phase II closed as of 03272000 Patients are followed at 1 month and then every 3 months for survival
PROJECTED ACCRUAL Approximately 15-20 patients will be accrued within 4-5 months for the phase I portion of the study A total of 15-30 patients will be accrued within 7-8 months for the phase II portion of the study closed as of 03272000
OUTLINE This is a multicenter dose-escalation study of epirubicin and docetaxel Patients receive epirubicin IV over 15 minutes followed by docetaxel IV over 60 minutes on day 1 Patients also receive filgrastim G-CSF subcutaneously on days 4-13 Treatment continues every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of epirubicin and docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose in which at least 2 of 6 patients experience dose-limiting toxicity Additional patients will be accrued to receive treatment at the recommended phase II dose phase II closed as of 03272000 Patients are followed at 1 month and then every 3 months for survival
PROJECTED ACCRUAL Approximately 15-20 patients will be accrued within 4-5 months for the phase I portion of the study A total of 15-30 patients will be accrued within 7-8 months for the phase II portion of the study closed as of 03272000
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000065138 | OTHER | PDQ | None |
| CAN-NCIC-MA15 | None | None | None |
| NCI-V96-1063 | None | None | None |