liposomal doxorubicin and gemcitabine in treating women with metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of combining liposomal doxorubicin with gemcitabine in treating women who have metastatic breast cancer.

objectives: * determine the objective response rate in women with metastatic breast cancer treated with doxorubicin hcl liposome and gemcitabine. * determine the duration of response, time to disease progression, and duration of survival of patients treated with this regimen. * determine the quality of life of patients treated with this regimen. * determine the quantitative toxicity of this regimen, in terms of incidence, type, and severity, in these patients. outline: this is a multicenter study. patients receive doxorubicin hcl liposome iv over 1 hour on day 1 and gemcitabine iv over 30 minutes on days 1 and 8. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. patients who achieve a complete response (cr) receive 2 courses beyond documentation of cr. quality of life is assessed at baseline, on day 1 of each course, and then at the end of study. patients are followed at 4 weeks and then every 3 months for 5 years. projected accrual: a total of 75 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed metastatic breast cancer * measurable disease * hormone receptor status: * not specified patient characteristics: age: * 18 and over sex: * female menopausal status: * not specified performance status: * karnofsky 60-100% life expectancy: * at least 3 months hematopoietic: * platelet count at least 100,000/mm\^3 * hemoglobin at least 9 g/dl * absolute neutrophil count at least 1,500/mm\^3 * no impaired bone marrow function hepatic: * bilirubin no greater than 2 mg/dl * ast and alt no greater than 2 times upper limit of normal (uln) * alkaline phosphatase no greater than 2 times uln (unless attributed to tumor) * no impaired hepatic function renal: * creatinine no greater than 2.5 mg/dl or * creatinine clearance at least 60 ml/min * no impaired renal function cardiovascular: * no prior cardiac disease within the past 5 years or * lvef at least 50% other: * no prior uncontrolled seizures * no uncontrolled systemic infection * no anthracycline resistance * no other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * no prior trastuzumab (herceptin) chemotherapy: * prior adjuvant therapy with anthracycline of no more than 320 mg/m\^2 allowed endocrine therapy: * not specified radiotherapy: * no prior radiotherapy to more than 1/3 of hematopoietic sites surgery: * not specified other: * at least 30 days since prior investigational medications and recovered * no more than 1 prior treatment regimen for metastatic disease

Keywords: stage iv breast cancer