combination chemotherapy in treating women with breast cancer that is metastatic or cannot be treated with surgery

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy in treating women who have breast cancer that is metastatic or cannot be treated with surgery.

objectives: * determine the response rate in women with locally unresectable or metastatic breast cancer treated with docetaxel, leucovorin calcium, and fluorouracil as second or third-line chemotherapy. * evaluate the toxic effects of this regimen in these patients. * determine the time to progression in patients treated with this regimen. outline: this is a multicenter study. patients receive docetaxel iv over 1 hour on day 1 and leucovorin calcium iv over 1 hour followed by fluorouracil iv over 5 minutes on days 1-3. treatment repeats every 4 weeks for 2-8 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months. projected accrual: a total of 21-45 patients will be accrued for this study within 44 months.

Eligibility criteria:
disease characteristics: * histologically confirmed breast cancer * metastatic or unresectable local disease * measurable or evaluable disease * no ascites or pleural effusion as only metastatic site * no brain or leptomeningeal metastases * hormone receptor status: * not specified patient characteristics: age: * 18 and over sex: * female menopausal status: * not specified performance status: * 0-2 life expectancy: * at least 3 months hematopoietic: * granulocyte count greater than 1,500/mm3 * platelet count greater than 100,000/mm3 hepatic: * bilirubin normal * sgot/sgpt less than 1.5 times upper limit of normal (uln) * alkaline phosphatase less than 2.5 times uln renal: * creatinine no greater than 2 times uln cardiovascular: * adequate cardiac function * no history of significant atherosclerotic coronary disease (e.g., uncontrolled angina) * no history of significant cardiac arrhythmia other: * no serious medical or psychiatric illness that would preclude study * no active uncontrolled bacterial, viral, or fungal infection * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * no prior high-dose chemotherapy and autologous transplantation chemotherapy: * at least 3 weeks since prior chemotherapy and recovered * no more than 2 prior chemotherapy regimens for metastatic breast cancer (in addition to adjuvant therapy) * no prior docetaxel * no prior high-dose chemotherapy and autologous transplantation * prior paclitaxel allowed endocrine therapy: * no concurrent hormonal therapy, except as contraception radiotherapy: * at least 3 weeks since prior radiotherapy and recovered * concurrent radiotherapy for relief of localized pain or obstruction allowed surgery: * at least 2 weeks since prior major surgery and recovered other: * no other concurrent cytotoxic agents

Keywords: stage iv breast cancer recurrent breast cancer stage iiib breast cancer