A PHASE I/II STUDY OF DOCETAXEL AND EPIRUBICIN AS FIRST LINE THERAPY FOR METASTATIC BREAST CANCER
OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of
docetaxel in combination with epirubicin and filgrastim (G-CSF) as first-line therapy in
women with metastatic breast cancer (phase II closed as of 03/27/2000). II. Determine the
pharmacokinetic profile of docetaxel and epirubicin in these patients. III. Evaluate the
toxicity of this regimen given at the recommended phase II dose. IV. Determine the response
rate and duration of response in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of epirubicin and docetaxel. Patients
receive epirubicin IV over 15 minutes followed by docetaxel IV over 60 minutes on day 1.
Patients also receive filgrastim (G-CSF) subcutaneously on days 4-13. Treatment continues
every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable
toxicity. 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 in which at
least 2 of 6 patients experience dose-limiting toxicity. Additional patients will be accrued
to receive treatment at the recommended phase II dose (phase II closed as of 03/27/2000).
Patients are followed at 1 month and then every 3 months for survival.
PROJECTED ACCRUAL: Approximately 15-20 patients will be accrued within 4-5 months for the
phase I portion of the study. A total of 15-30 patients will be accrued within 7-8 months
for the phase II portion of the study (closed as of 03/27/2000).
Primary Purpose: Treatment
Maureen E. Trudeau, BSc, MA, MD, FRCPC
Edmond Odette Cancer Centre at Sunnybrook
United States: Federal Government