NCT00006121

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.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2 breast-cancer

Geographic Reach
7 countries

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2002

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

October 8, 2003

Completed
Last Updated

July 24, 2012

Status Verified

July 1, 2012

Enrollment Period

2 years

First QC Date

August 3, 2000

Last Update Submit

July 23, 2012

Conditions

Breast Cancer

Keywords

stage III breast cancerstage IV breast cancerrecurrent breast cancer

Interventions

oxaliplatinDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

Kaiser Franz Josef Hospital

Vienna (Wien), A-1100, Austria

Location

Institut Jules Bordet

Brussels (Bruxelles), 1000, Belgium

Location

CHU de la Timone

Marseille, 13385, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Centre Eugene Marquis

Rennes, 35064, France

Location

Universitats-Krankenhaus Eppendorf

Hamburg, D-20246, Germany

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

Location

Institute of Oncology, Ljubljana

Ljubljana, Sl-1000, Slovenia

Location

Beatson Oncology Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Pierre Fumoleau, MD, PhD

    Centre Georges Francois Leclerc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2000

First Posted

October 8, 2003

Study Start

May 1, 2000

Primary Completion

May 1, 2002

Last Updated

July 24, 2012

Record last verified: 2012-07

Locations

BE(1)SL(1)GB(1)DE(1)AU(1)IL(2)FR(3)