Breast Cancer
Conditions
Keywords
stage III breast cancer, stage IV breast cancer, recurrent breast cancer
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Countries
Austria, Belgium, France, Germany, Israel, Slovenia, United Kingdom