gemcitabine in treating women with metastatic breast cancer previously treated with doxorubicin and paclitaxel

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 gemcitabine in treating women with metastatic breast cancer previously treated with doxorubicin and paclitaxel.

objectives: * determine the objective response rate to gemcitabine in women with metastatic breast cancer previously treated with two to four chemotherapy regimens, including doxorubicin and paclitaxel. * characterize the nature of toxicity of gemcitabine in this patient population. * determine the response duration to gemcitabine in this patient population. outline: patients receive gemcitabine iv over 30 minutes once weekly for 3 consecutive weeks (days 1, 8, and 15) followed by 1 week of rest. treatment continues every 4 weeks in the absence of disease progression or unacceptable toxic effects. patients are followed until death. projected accrual: a total of 14-30 patients will be accrued for this study within 13 months.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic breast cancer * bidimensionally measurable disease * no bone scan abnormalities alone * lytic lesions in conjunction with bone scan abnormalities allowed * no pure blastic bone metastases * no pleural or peritoneal effusions * no previously irradiated lesions * must have received 2-4 prior chemotherapy regimens, including paclitaxel and doxorubicin, for breast cancer * brain metastases allowed if other measurable disease exists * no uncontrolled or life threatening brain lesions * no carcinomatous meningitis * hormone receptor status: * not specified patient characteristics: age: * 18 and over sex: * female menopausal status: * not specified performance status: * karnofsky 60-100% life expectancy: * not specified hematopoietic: * granulocyte count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * ast/alt no greater than 5 times upper limit of normal renal: * calcium no greater than 11.0 mg/dl other: * not pregnant * negative pregnancy test * no history of other malignancy except carcinoma in situ of the cervix or curatively treated nonmelanoma skin cancer * no other serious medical illnesses, including severe infection and severe malnutrition prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered * no other concurrent chemotherapy endocrine therapy: * prior hormonal therapies for stage iv disease and/or adjuvant therapy allowed * at least 3 weeks since prior hormonal therapy radiotherapy: * see disease characteristics * no prior radiotherapy to greater than 30% of the marrow bearing bone * at least 4 weeks since prior radiotherapy and recovered * no concurrent radiotherapy to the only measurable lesion surgery: * recovered from prior surgery * no concurrent surgery to the only measurable lesion other: * no concurrent nonprotocol treatment

Keywords: stage iv breast cancer recurrent breast cancer