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A Phase I Study to Determine the Maximum Tolerated Dose of Daunoxome as Therapy for the Treatment of Metastatic Breast Cancer

Phase 1
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven metastatic breast cancer
Measurable disease No bone metastases only No CNS involvement or leptomeningeal disease
Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance
status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL
Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) AST or ALT less than 2
times ULN (less than 5 times ULN if liver metastases present) Renal: Creatinine normal
Cardiovascular: Left ventricular ejection fraction at least 50% or normal by
echocardiogram or MUGA scan No active ischemic heart disease No uncontrolled hypertension
No poorly controlled atrial arrhythmias, symptomatic angina pectoris, or myocardial
infarction within the past 6 months No symptomatic congestive heart failure, percutaneous
transluminal coronary angioplasty, or coronary artery bypass graft surgery within the past
12 months Other: No other primary cancer within the past 5 years except curatively treated
nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception No condition
that would preclude informed consent or compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy No
prior bone marrow transplantation Chemotherapy: Prior nonanthracycline based chemotherapy
for breast cancer allowed No prior anthracycline based chemotherapy for metastatic disease
Prior anthracycline based adjuvant chemotherapy allowed if: At least 6 months have elapsed
from completion of adjuvant therapy until the detection of metastatic disease Cumulative
dose no greater than 300 mg/m2 Endocrine therapy: At least 3 weeks since prior hormonal
therapy No concurrent hormonal or corticosteroid therapy for breast cancer Radiotherapy:
At least 2 weeks since prior radiotherapy and recovered No concurrent radiotherapy
Surgery: Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Kenneth O'Byrne, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospitals, Leicester


United States: Federal Government

Study ID:




Start Date:

December 1997

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms