Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066443
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2003-08-06
Brief Title:
Epirubicin Docetaxel and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Study Of Increasing Doses Of Epirubicin And Docetaxel Plus Pegfilgrastim For Locally Advanced Or Inflammatory 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 such as epirubicin and docetaxel use different ways to stop tumor cells from dividing so they stop growing or die Colony-stimulating factors such as pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase III trial to study the effectiveness of combining epirubicin and docetaxel with pegfilgrastim in treating women who have locally advanced or inflammatory breast cancer
PURPOSE Phase III trial to study the effectiveness of combining epirubicin and docetaxel with pegfilgrastim in treating women who have locally advanced or inflammatory breast cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and recommended phase II dose of docetaxel and epirubicin when given with pegfilgrastim in women with locally advanced or inflammatory breast cancer Phase I group 1 closed to accrual as of 91304 and Phase II group 1 closed to accrual as of 51006
Determine the toxicity of this regimen in these patients
Determine the clinical and pathological response rate and duration of response in patients treated with this regimen
Determine drug sensitivity and resistance in patients treated with this regimen
Determine prognostic and predictive markers in patients treated with this regimen
OUTLINE This is a nonrandomized multicenter dose-escalation study of docetaxel and epirubicin
Phase I
Group 1 21-day regimen closed to accrual as of 091304 Patients receive epirubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 1 and pegfilgrastim subcutaneously on day 2 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with objective response after 6 courses may receive additional therapy at the discretion of the physician
Group 2 14-day regimen Patients receive epirubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 1 and pegfilgrastim subcutaneously on day 2 Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity Patients with objective response after 8 courses may receive additional therapy at the discretion of the physician
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 at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II
Group 1 21-day regimen closed to accrual as of 51006 Patients receive treatment as in phase I with epirubicin and docetaxel at the recommended Phase II dose
Group 2 14-day regimen Patients receive treatment as in phase I with epirubicin and docetaxel at the recommended Phase II dose
Patients are followed at 1 month every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL Approximately 90 patients will be accrued for this study
Determine the maximum tolerated dose and recommended phase II dose of docetaxel and epirubicin when given with pegfilgrastim in women with locally advanced or inflammatory breast cancer Phase I group 1 closed to accrual as of 91304 and Phase II group 1 closed to accrual as of 51006
Determine the toxicity of this regimen in these patients
Determine the clinical and pathological response rate and duration of response in patients treated with this regimen
Determine drug sensitivity and resistance in patients treated with this regimen
Determine prognostic and predictive markers in patients treated with this regimen
OUTLINE This is a nonrandomized multicenter dose-escalation study of docetaxel and epirubicin
Phase I
Group 1 21-day regimen closed to accrual as of 091304 Patients receive epirubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 1 and pegfilgrastim subcutaneously on day 2 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with objective response after 6 courses may receive additional therapy at the discretion of the physician
Group 2 14-day regimen Patients receive epirubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 1 and pegfilgrastim subcutaneously on day 2 Treatment repeats every 14 days for up to 8 courses in the absence of disease progression or unacceptable toxicity Patients with objective response after 8 courses may receive additional therapy at the discretion of the physician
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 at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II
Group 1 21-day regimen closed to accrual as of 51006 Patients receive treatment as in phase I with epirubicin and docetaxel at the recommended Phase II dose
Group 2 14-day regimen Patients receive treatment as in phase I with epirubicin and docetaxel at the recommended Phase II dose
Patients are followed at 1 month every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL Approximately 90 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| CAN-NCIC-MA22 | None | None | None |
| CDR0000316237 | OTHER | PDQ | None |