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.
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
Israel2 sites
Rambam Medical Center
Haifa, 31096
Schneider Children's Medical Center of Israel
Petah Tikva, 49202
United Kingdom1 site
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
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.
oxaliplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2003 (estimated)
- Study startMay 2000
- Primary completionMay 2002
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pierre Fumoleau, MD, PhD, Study chair, Centre Georges Francois Leclerc
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy
- ClinicalTrials.gov ID
- NCT00006121
- Acronym / sponsor ID
- EORTC-16001-10005
- Conditions
- Breast Cancer
- Keywords
- stage III breast cancer, stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 18 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- May 2000
- Primary completion
- May 2002 (actual)
- First posted
- 8 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxaliplatin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Fumoleau, MD, PhD study chair
Centre Georges Francois Leclerc
10 sites in 7 countries: see every site and its status.
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.