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

July 23, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna (Wien), Austria, A-1100
        • Kaiser Franz Josef Hospital
  • Belgium
      • Brussels (Bruxelles), Belgium, 1000
        • Institut Jules Bordet
  • France
      • Marseille, France, 13385
        • CHU de la Timone
      • Nantes-Saint Herblain, France, 44805
        • CRLCC Nantes - Atlantique
      • Rennes, France, 35064
        • Centre Eugene Marquis
  • Germany
      • Hamburg, Germany, D-20246
        • Universitäts-Krankenhaus Eppendorf
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Petah-Tikva, Israel, 49202
        • Schneider Children's Medical Center of Israel
  • Slovenia
      • Ljubljana, Slovenia, Sl-1000
        • Institute of Oncology, Ljubljana
  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Beatson Oncology Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Pierre Fumoleau, MD, PhD, Centre Georges Francois Leclerc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (Actual)

May 1, 2002

Study Registration Dates

First Submitted

August 3, 2000

First Submitted That Met QC Criteria

October 7, 2003

First Posted (Estimate)

October 8, 2003

Study Record Updates

Last Update Posted (Estimate)

July 24, 2012

Last Update Submitted That Met QC Criteria

July 23, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-16001-10005
  • EORTC-16001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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