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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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ClinicalTrials.gov Identifier: NCT00006121
Recruitment Status : Terminated (low accrual)
First Posted : October 8, 2003
Last Update Posted : July 24, 2012
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

August 3, 2000
October 8, 2003
July 24, 2012
May 2000
May 2002   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006121 on ClinicalTrials.gov Archive Site
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Oxaliplatin in Treating Women With Advanced or Metastatic Breast Cancer That Has Not Responded to Previous Chemotherapy
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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Breast Cancer
Drug: oxaliplatin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
18
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May 2002   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   France,   Germany,   Israel,   Slovenia,   United Kingdom
 
 
NCT00006121
EORTC-16001-10005
EORTC-16001
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European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: Pierre Fumoleau, MD, PhD Centre Georges Francois Leclerc
European Organisation for Research and Treatment of Cancer - EORTC
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP