Oxaliplatin in Treating Women With Advanced or Metastatic Breast Cancer That Has Not Responded to Previous Chemotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: oxaliplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oxaliplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III breast cancer, stage IV breast cancer, recurrent breast cancer