capecitabine in treating patients with metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well capecitabine works in treating patients with metastatic breast cancer.

objectives: primary * determine the response rate in patients with metastatic breast cancer treated with a fixed-dose of capecitabine. secondary * determine the clinical benefit, time to treatment failure (ttf), safety, and toxicity profile of this regimen in these patients. * determine the pharmacokinetics (pk) and pharmacogenetics in these patients. * correlate pharmacodynamic effects of this drug with toxicity and response in these patients. * determine compliance and adherence to this regimen and correlate with pk parameters in these patients. outline: this is an open-label study. patients receive a fixed-dose of oral capecitabine twice daily on days 1-14. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed periodically. projected accrual: a total of 45 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast * evidence of metastatic involvement (stage iv disease) * patients must have measurable disease * at least one measurable lesion as defined by the response evaluation criteria in solid tumors (recist) * treated brain metastases (surgery or radiation therapy) allowed if clinically stable * patients with leptomeningeal disease are ineligible * hormone receptor status: * not specified patient characteristics: * eastern cooperative oncology group (ecog) performance status 0-2 * male or female * menopausal status not specified * absolute neutrophil count (anc) ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * creatinine clearance \> 50 ml/min * fertile patients must use effective contraception * no history of another severe and/or life-threatening medical disease * no other active primary malignancy * not pregnant or nursing * negative pregnancy test * patients with asymptomatic hiv infection are eligible * liver dysfunction score ≤ 9 * no pre-existing liver disease (i.e., cirrhosis or active viral hepatitis) * no active gastrointestinal malabsorption illness * no clinically significant cardiac disease, including the following: * congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication, or myocardial infarction within the past six months * no prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency * no history of uncontrolled seizures or central nervous system disorders * no significant history of noncompliance to medical regimens * no clinically significant psychiatric disability that would preclude study compliance prior concurrent therapy: * no previous capecitabine * up to 3 prior cytotoxic regimens allowed for metastatic disease * prior noncytotoxic therapy allowed (e.g., hormonal treatment or trastuzumab) * no other concurrent therapies intended to treat the primary condition including chemotherapy, biologic agents, or immunotherapy * no concurrent anti-estrogen therapy, radiation therapy, or investigational systemic therapy * no other concurrent investigational drugs * no concurrent use of the following drugs: warfarin for full anticoagulation, cimetidine, or azidothymidine (azt) * mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed * at least 4 weeks since prior sorivudine or brivudine * concurrent use of bisphosphonates allowed if initiated before beginning study therapy * concurrent use of megestrol acetate suspension as an appetite stimulant allowed

Keywords: stage iv breast cancer male breast cancer recurrent breast cancer