Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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 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.

Further Study Information

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.

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.

Eligibility 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

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/mm^3

• Platelet count at least 100,000/mm^3

• 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 core biopsies once prior to registration and core biopsies at 2 other timepoints while on study

• Geographically accessible for treatment and follow-up

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

Trial Contact Information

Trial Lead Organizations/Sponsors

NCIC-Clinical Trials Group

Maureen E. Trudeau

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00066443
Information obtained from ClinicalTrials.gov on December 14, 2011

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