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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
oxaliplatin
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage III breast cancer, stage IV breast cancer, recurrent breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Franz Josef Hospital
  • Institut Jules Bordet
  • CHU de la Timone
  • CRLCC Nantes - Atlantique
  • Centre Eugene Marquis
  • Universitats-Krankenhaus Eppendorf
  • Rambam Medical Center
  • Schneider Children's Medical Center of Israel
  • Institute of Oncology, Ljubljana
  • Beatson Oncology Centre

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 3, 2000
Last Updated
July 23, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00006121
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
May 2000 (undefined)
Primary Completion Date
May 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage III breast cancer, stage IV breast cancer, recurrent breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
oxaliplatin

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Fumoleau, MD, PhD
Organizational Affiliation
Centre Georges Francois Leclerc
Official's Role
Study Chair
Facility Information:
Facility Name
Kaiser Franz Josef Hospital
City
Vienna (Wien)
ZIP/Postal Code
A-1100
Country
Austria
Facility Name
Institut Jules Bordet
City
Brussels (Bruxelles)
ZIP/Postal Code
1000
Country
Belgium
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CRLCC Nantes - Atlantique
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35064
Country
France
Facility Name
Universitats-Krankenhaus Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Schneider Children's Medical Center of Israel
City
Petah-Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
Institute of Oncology, Ljubljana
City
Ljubljana
ZIP/Postal Code
Sl-1000
Country
Slovenia
Facility Name
Beatson Oncology Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom

12. IPD Sharing Statement

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

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