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AzTrials

Breast CancerPhase 2NCT00006121

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

A Phase 2 study testing oxaliplatin in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
oxaliplatin
How many people
18 participants
Where
10 sitesin 7 countries
Study dates
May 2000to May 2002
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

10 sites in 7 countries.

10 sites in 7 countries

France3 sites
  • CHU de la Timone

    Marseille, 13385

  • CRLCC Nantes - Atlantique

    Nantes-Saint Herblain, 44805

  • Centre Eugene Marquis

    Rennes, 35064

Other trials in France

Israel2 sites
  • Rambam Medical Center

    Haifa, 31096

  • Schneider Children's Medical Center of Israel

    Petah Tikva, 49202

Other trials in Israel

Austria1 site
  • Kaiser Franz Josef Hospital

    Vienna (Wien), A-1100

Other trials in Austria

Belgium1 site
  • Institut Jules Bordet

    Brussels (Bruxelles), 1000

Other trials in Belgium

Germany1 site
  • Universitats-Krankenhaus Eppendorf

    Hamburg, D-20246

Other trials in Germany

Slovenia1 site
  • Institute of Oncology, Ljubljana

    Ljubljana, Sl-1000

Other trials in Slovenia

United Kingdom1 site
  • Beatson Oncology Centre

    Glasgow, Scotland, G11 6NT

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
oxaliplatin
Keywords
stage III breast cancer, stage IV breast cancer, recurrent breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2003 (estimated)
  2. Study startMay 2000
  3. Primary completionMay 2002

Why it stopped: low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006121
Sponsor's protocol ID
EORTC-16001-10005
Other IDs
EORTC-16001
Status last verified
Jul 2012
First submitted
3 Aug 2000
Last updated
24 Jul 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oxaliplatin in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France, Israel, Austria, Belgium, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: low accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2012.

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