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

Phase 2

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT00006121
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Timeline

• Study Start: 2000-05
• Study First Submitted: 2000-08-03
• Primary Completion: 2002-05
• Study First Submitted QC: 2003-10-07
• Study First Posted: 2003-10-08
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-23
• Last Update Posted: 2012-07-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (10)

Rambam Medical Center; 🇮🇱 Haifa, Israel

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

Universitats-Krankenhaus Eppendorf; 🇩🇪 Hamburg, Germany

Centre Eugene Marquis; 🇫🇷 Rennes, France

Beatson Oncology Centre; 🇬🇧 Glasgow, Scotland, United Kingdom

Schneider Children's Medical Center of Israel; 🇮🇱 Petah-Tikva, Israel

Institute of Oncology, Ljubljana; 🇸🇮 Ljubljana, Slovenia