Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00066443|
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : November 3, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: pegfilgrastim Drug: docetaxel Drug: epirubicin hydrochloride||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study Of Increasing Doses Of Epirubicin And Docetaxel Plus Pegfilgrastim For Locally Advanced Or Inflammatory Breast Cancer|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
U.S. FDA Resources
|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
- Toxic effects [ Time Frame: 7 years ]Findings were presented at ASCO 2010
- Response (phase II) [ Time Frame: 12 years ]Response was presented at ASCO 2010. Duration of response will be analyzed in 2015
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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||Toronto Sunnybrook Regional Cancer Centre|