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Brief Title: Oxaliplatin in Treating Women With Advanced or Metastatic Breast Cancer That Has Not Responded to Previous Chemotherapy
Official Title: Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy
Study ID: NCT00006121
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Kaiser Franz Josef Hospital, Vienna (Wien), , Austria
Institut Jules Bordet, Brussels (Bruxelles), , Belgium
CHU de la Timone, Marseille, , France
CRLCC Nantes - Atlantique, Nantes-Saint Herblain, , France
Centre Eugene Marquis, Rennes, , France
Universitats-Krankenhaus Eppendorf, Hamburg, , Germany
Rambam Medical Center, Haifa, , Israel
Schneider Children's Medical Center of Israel, Petah-Tikva, , Israel
Institute of Oncology, Ljubljana, Ljubljana, , Slovenia
Beatson Oncology Centre, Glasgow, Scotland, United Kingdom
Name: Pierre Fumoleau, MD, PhD
Affiliation: Centre Georges Francois Leclerc
Role: STUDY_CHAIR