A Phase I Study to Determine the Maximum Tolerated Dose of Daunoxome as Therapy for the Treatment of Metastatic Breast Cancer
OBJECTIVES: I. Determine the maximum tolerated dose of daunorubicin liposomal in patients
with metastatic breast cancer. II. Assess the antineoplastic activity and safety profile of
this regimen in these patients.
OUTLINE: This is a dose escalation study. Patients receive daunorubicin liposomal IV over a
minimum of 2 hours on day 1. Treatment repeats every 3 weeks for a maximum of 8 courses in
the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive
escalating doses of daunorubicin liposomal until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting
toxicity. Patients with stable or responding disease are followed at 1 and 3 months, then
every 3 months for 1 year.
PROJECTED ACCRUAL: Approximately 15-20 patients will be accrued for this study within 1
Primary Purpose: Treatment
Kenneth O'Byrne, MD
University Hospitals, Leicester
United States: Federal Government