oxaliplatin in treating women with advanced or metastatic breast cancer that has not responded to previous chemotherapy

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 oxaliplatin in treating women who have advanced or metastatic breast cancer that has not responded to previous chemotherapy.

objectives: * determine the therapeutic activity of oxaliplatin in patients with advanced or metastatic breast cancer following failure of anthracycline/taxane based chemotherapy. * determine objective response, duration of response, and time to progression in these patients when treated with this regimen. * determine the acute side effects of this regimen in these patients. outline: this is a multicenter study. patients receive oxaliplatin iv over 2 hours on day 1. treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. patients are followed every 6 weeks until disease progression and then every 3 months for survival. projected accrual: a total of 27-40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed advanced or metastatic breast cancer * bidimensionally measurable disease * at least one lesion at least 2 cm in one dimension by ct scan or mri * must have failed prior anthracycline/taxane based chemotherapy as defined by one of the following: * stage iv disease treated with anthracycline/taxane combination as first line therapy for advanced or metastatic disease * stage iv disease treated with first line anthracycline therapy and second line taxane therapy for advanced or metastatic disease * any adjuvant treatment other than anthracycline based therapy followed by anthracycline/taxane combination as first line therapy for advanced or metastatic disease * any adjuvant therapy other than anthracycline based therapy followed by first line anthracycline based therapy and second line taxane based therapy for advanced or metastatic disease * adjuvant anthracycline based therapy followed by relapse after 6 months treated with anthracycline/taxane combination as first line therapy or first line anthracycline based therapy and second line taxane based therapy for advanced or metastatic disease * adjuvant anthracycline based therapy followed by relapse within 6 months treated with first line taxane based therapy for advanced or metastatic disease * disease progression within 6 months of last taxane based chemotherapy * no brain metastases * hormonal receptor status: * not specified patient characteristics: age: * 18 and over sex: * female menopausal status: * not specified performance status: * who 0-2 life expectancy: * at least 3 months hematopoietic: * absolute neutrophil count greater than 2,000/mm\^3 * platelet count greater than 100,000/mm\^3 hepatic: * bilirubin less than 1.5 times upper limit of normal (uln) * alkaline phosphatase and transaminases no greater than 2.5 times uln (no greater than 5 times uln in case of liver metastases) renal: * creatinine less than 1.25 times uln cardiovascular: * lvef at least 50% if prior total dose of doxorubicin 550 mg/m2 or greater, epirubicin 900 mg/m2 or greater, or pirarubicin 700 mg/m2 or greater * no prior or active congestive heart failure, myocardial infarction, or angina * no uncontrolled hypertension or arrhythmia other: * no unstable systemic disease * no active infection * no grade 2 or greater peripheral neuropathy * no psychological, familial, sociological, or geographical condition that would preclude study prior concurrent therapy: biologic therapy: * no prior high dose chemotherapy with hematopoietic rescue * no concurrent immunotherapy * no concurrent filgrastim (g-csf) or sargramostim (gm-csf) for prevention of neutropenia chemotherapy: * see disease characteristics * at least 4 weeks since prior chemotherapy * at least 1 prior taxane based chemotherapy for advanced or metastatic disease * no prior high dose chemotherapy with hematopoietic rescue * no prior platinum based chemotherapy * no prior taxane chemotherapy other than docetaxel or paclitaxel * no prior adjuvant or neoadjuvant therapy with taxane/anthracycline based combination chemotherapy endocrine therapy: * no concurrent steroids except in case of allergy prevention, emesis prophylaxis, or long term treatment for more than 3 months prior to study * no concurrent hormonal anticancer therapy radiotherapy: * no prior radiotherapy to study site unless evidence of disease progression * concurrent local radiotherapy allowed for pain relief surgery: * at least 4 weeks since prior major surgery other: * at least 4 weeks since prior anticancer and/or investigational drug * no concurrent bisphosphonates unless started at least 2 months prior to study * no other concurrent anticancer therapy * no other concurrent experimental drugs

Keywords: stage iii breast cancer stage iv breast cancer recurrent breast cancer