s0029 docetaxel in treating older 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 in treating older women who have metastatic breast cancer.

objectives: * determine the feasibility of treating elderly women with metastatic breast cancer with docetaxel. * determine the overall survival, 2-year survival, and response (confirmed and unconfirmed complete and partial) in patients treated with this drug. * determine the toxicity and tolerability of this drug in these patients. * determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status in elderly cancer patients. * determine the parameters of clinical pharmacology of this drug in elderly patients and in patients under 60 years of age. * determine, preliminarily, the genetic polymorphisms and gene expression levels of enzymes involved in drug metabolism and resistance in patients treated with this drug. outline: patients are stratified according to age (70 and over vs under 60). patients receive docetaxel iv over 1 hour on day 1. treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 3 years. projected accrual: approximately 80 patients (60 patients age 70 and over and 20 patients under age 60) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed breast cancer * distant metastatic disease confirmed by histology, cytology, or strong clinical evidence * measurable disease * no known brain or cns metastases * hormone receptor status: * not specified patient characteristics: age: * 70 and over or * under 60 sex: * female menopausal status: * not specified performance status: * zubrod 0-2 life expectancy: * not specified hematopoietic: * absolute granulocyte count at least 1,500/mm\^3 * hemoglobin at least 9 g/dl * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than upper limit of normal (uln) * sgot or sgpt no greater than 1.5 times uln (2.0 times uln if liver metastases are present) * alkaline phosphatase no greater than 1.5 times uln (2.0 times uln if liver metastases are present) renal: * creatinine no greater than uln other: * not pregnant or nursing * fertile patients must use effective contraception * hiv negative * no other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage i or ii cancer in complete remission prior concurrent therapy: biologic therapy: * no concurrent immunotherapy for breast cancer chemotherapy: * prior adjuvant or neoadjuvant chemotherapy allowed * prior adjuvant taxanes allowed * no other concurrent chemotherapy for breast cancer endocrine therapy: * prior hormonal therapy in the adjuvant setting or for metastatic disease allowed * no concurrent hormonal therapy for breast cancer radiotherapy: * no concurrent radiotherapy for breast cancer surgery: * not specified other * no more than 1 prior regimen for advanced, recurrent, or metastatic disease

Keywords: stage iv breast cancer recurrent breast cancer