Gemcitabine and Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer

OBJECTIVES:

I. Determine the objective response rate, duration of response, time to disease progression,
and duration of survival of women with metastatic breast cancer when treated with gemcitabine
and doxorubicin HCl liposome.

II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this
treatment regimen in these patients.

OUTLINE: Patients receive gemcitabine intravenous (IV) over 30 minutes on days 1 and 8 and
doxorubicin HCl liposome IV over 2.5 hours on day 1. Treatment continues every 21 days in the
absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks.

PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within 20 months.

DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer Bidimensionally
measurable disease No uncontrolled brain metastases or leptomeningeal disease Brain
metastases treated with surgery and/or radiotherapy allowed if neurologic status is stable
two weeks after last dose of dexamethasone Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified
Performance status: Zubrod 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet
count at least 100,000/mm3 Hemoglobin at least 8 g/dL Absolute neutrophil count at least
1,500/mm3 Hepatic: Bilirubin no greater than 1.2 mg/dL SGPT less than 1.5 times upper limit
of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: LVEF at least 50% by
MUGA No cardiac disease or congestive heart failure Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception No other concurrent
serious illness, psychiatric disorder, or active infection No other prior or concurrent
malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of
the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior high-dose chemotherapy followed by
bone marrow transplantation Chemotherapy: See Biologic Therapy At least 3 weeks since prior
chemotherapy and recovered No prior doxorubicin HCl liposome or gemcitabine Prior
neoadjuvant chemotherapy allowed At least 12 months since prior adjuvant
anthracycline-based therapy and no evidence of anthracycline resistance (i.e., developed
progressive disease while receiving adjuvant therapy or within 6 months of completing
adjuvant therapy) Prior mitoxantrone allowed if total dose was no greater than 105 mg/m2 IV
bolus or 140 mg/m2 IV continuous infusion Prior doxorubicin allowed if total dose was no
greater than 300 mg/m2 IV bolus or 400 mg/m2 IV continuous infusion No prior chemotherapy
for metastatic disease Endocrine therapy: Prior adjuvant and/or palliative hormonal therapy
allowed Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy
and recovered Surgery: See Disease Characteristics Prior surgery allowed Other: At least 3
weeks since prior investigational study Concurrent pamidronate allowed if bone not the only
site of disease