Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer
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 person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin and docetaxel with pegfilgrastim in treating women who have locally advanced or inflammatory breast cancer.
Drug: epirubicin hydrochloride
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study Of Increasing Doses Of Epirubicin And Docetaxel Plus Pegfilgrastim For Locally Advanced Or Inflammatory Breast Cancer|
- Toxic effects [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]Findings were presented at ASCO 2010
- Response (phase II) [ Time Frame: 12 years ] [ Designated as safety issue: No ]Response was presented at ASCO 2010. Duration of response will be analyzed in 2015
|Study Start Date:||February 2003|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
|Experimental: Pegfilgrastim, docetaxel and epirubicin||
Dose escalation schedule A&B = 6mg fixed dose once per cycle on day 2Drug: docetaxel
Dose Escalation schedule A = 75-85 mg/m2 Dose Escalation schedule B = 50-75 mg/m2Drug: epirubicin hydrochloride
Dose escalation schedule A = 75-120 mg/m2 IV Dose escalation schedule B = 50-90 mg/m2 IV
- 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 9/13/04 and Phase II, group 1 closed to accrual as of 5/10/06)
- 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 09/13/04): 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 5/10/06): 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066443
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Canada, New Brunswick|
|Atlantic Health Sciences Corporation|
|Saint John, New Brunswick, Canada, E2L 4L2|
|Odette Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|CHA-Hopital Du St-Sacrement|
|Quebec City, Quebec, Canada, G1S 4L8|
|Study Chair:||Maureen E. Trudeau, BSc, MA, MD, FRCPC||Edmond Odette Cancer Centre at Sunnybrook|