docetaxel and ifosfamide 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 docetaxel and ifosfamide in treating women who have metastatic breast cancer.

objectives: * determine the efficacy of docetaxel and ifosfamide as first-line chemotherapy in women with metastatic breast cancer. * determine the response rate and duration of response of patients treated with this regimen. * determine the time to treatment failure and survival of patients treated with this regimen. * determine the toxicity of this regimen in these patients. * determine the quality of life of patients treated with this regimen. outline: this is a multicenter study. patients receive docetaxel iv over 1 hour on day 1 and ifosfamide iv over 1 hour (beginning 1 hour after docetaxel infusion) on days 1-3. treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. quality of life is assessed at baseline, every month during study, and then every 3 months after completion of study. patients are followed every 3 months. projected accrual: a total of 15-42 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic breast cancer * bidimensionally measurable lesions * the following are not considered measurable: * bone lesions * leptomeningeal disease * ascites * pleural/pericardial effusion * inflammatory breast disease * lymphangitis cutis/pulmonis * disease progression after hormonal therapy allowed provided at least 1 month since last therapeutic manipulation * no cns metastases * hormone receptor status: * not specified patient characteristics: age: * 21 to 75 sex: * female menopausal status: * not specified performance status: * ecog 0-2 or * zubrod 0-2 life expectancy: * more than 12 weeks hematopoietic: * wbc at least 4,000/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 11 g/dl hepatic: * bilirubin no greater than 1.25 times upper limit of normal (uln) * sgot no greater than 1.25 times uln renal: * creatinine clearance at least 60 ml/min cardiovascular: * no history of congestive heart failure * no myocardial infarction within the past 6 months * no active ischemic heart disease * no uncontrolled hypertension other: * not pregnant * no other prior or concurrent malignancy except properly treated basal cell skin cancer or carcinoma in situ of the cervix * no other medical or psychiatric diseases that would preclude study * no geographical situation that would preclude study * no history of alcohol abuse prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior adjuvant chemotherapy including ifosfamide or docetaxel * no prior systemic chemotherapy for metastatic breast cancer endocrine therapy: * see disease characteristics * no concurrent corticoids, gestagens, or androgens unless strictly indicated radiotherapy: * not specified surgery: * not specified other: * no concurrent drinks containing caffeine or alcohol

Keywords: stage iv breast cancer recurrent breast cancer