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Phase I/II Study of Epirubicin, Docetaxel, and 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)

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II, Phase I Treatment Active 16 and over Other CAN-NCIC-MA22
NCT00066443, MA22

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 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.

Entry Criteria

Disease Characteristics:

Histologically confirmed invasive adenocarcinoma of the breast, meeting any of the following criteria:
- T4, NX, M0
- Any T, N2-N3, M0
- Inflammatory breast cancer (redness over at least one-third of the breast), M0

No evidence of metastatic disease by chest x-ray, abdominal ultrasound or CT scan and bone scan

Diagnosed within the past 8 weeks

Hormone receptor status:
- Not specified

Prior/Concurrent Therapy:

Biologic therapy

No prior immunotherapy for breast cancer

Chemotherapy

No prior chemotherapy for breast cancer

Endocrine therapy

No prior hormonal therapy for breast cancer
No concurrent corticosteroids except for premedication or hypersensitivity reaction
No concurrent oral contraception

Radiotherapy

No prior radiotherapy for breast cancer

Surgery

No prior surgery for breast cancer other than biopsy

Other

No prior systemic therapy for breast cancer
No other concurrent investigational drugs or anticancer treatment
No concurrent preventative IV antibiotics

Patient Characteristics:

Age

16 and over

Sex

Female

Menopausal status

Not specified

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Absolute granulocyte count at least 2,000/mm³
Platelet count at least 100,000/mm³
Hemoglobin at least 10 g/dL

Hepatic

Bilirubin less than upper limit of normal (ULN)
Must meet criteria for 1 of the following:
- ALT and AST no greater than 1.5 times ULN AND alkaline phosphatase no greater than 2.5 times ULN
- ALT and AST normal AND alkaline phosphatase no greater than 5 times ULN

Renal

Creatinine no greater than 1.5 times ULN

Cardiovascular

Resting LVEF normal by MUGA or echocardiogram
No congestive heart failure
No angina pectoris
No myocardial infarction within the past year
No uncontrolled hypertension
No uncontrolled arrhythmias

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective non-hormonal contraception
No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
No symptomatic peripheral neuropathy grade 2 or greater
No active infection
No history of significant neurological or psychiatric disorders, including dementia or seizures
No peptic ulcer
No unstable diabetes mellitus
No contraindication to dexamethasone
No known sensitivity to E. coli-derived or polyethylene glycol products
Willing to undergo 1 core biopsy prior to registration and 2 core biopsies while on study
Geographically accessible for treatment and follow-up

Expected Enrollment

A total of 30-50 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Toxic effects
Response (phase II)

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.

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Maureen Trudeau, BSc, MA, MD, FRCPC, Protocol chair
Ph: 416-480-5145
Email: maureen.trudeau@sunnybrook.ca

Trial Sites

Canada

Manitoba

Winnipeg

CancerCare Manitoba

Debjani Grenier
Ph: 204-235-3728

New Brunswick

Saint John

Saint John Regional Hospital

Margot Burnell
Ph: 506-648-6884

Ontario

Toronto

Edmond Odette Cancer Centre at Sunnybrook

Maureen E. Trudeau
Ph: 416-480-5145

Princess Margaret Hospital

Mark Clemons
Ph: 416-946-4543

Quebec

Quebec City

Hopital du Saint-Sacrement - Quebec

Louise Provencher
Ph: 418-682-7511

Registry Information

Official Title		A Phase I/II Study Of Increasing Doses Of Epirubicin And Docetaxel Plus Pegfilgrastim For Locally Advanced Or Inflammatory Breast Cancer

Trial Start Date		2003-02-25

Trial Completion Date		2009-12-01 (estimated)

Registered in ClinicalTrials.gov		NCT00066443

Date Submitted to PDQ		2003-06-18

Information Last Verified		2009-02-23

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.