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

Tracking Information
First Submitted Date ICMJE	August 3, 2000
First Posted Date ICMJE	October 8, 2003
Last Update Posted Date	July 24, 2012
Study Start Date ICMJE	May 2000
Actual Primary Completion Date	May 2002 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00006121 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Oxaliplatin in Treating Women With Advanced or Metastatic Breast Cancer That Has Not Responded to Previous Chemotherapy
Official Title ICMJE	Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Primary Purpose: Treatment
Condition ICMJE	Breast Cancer
Intervention ICMJE	Drug: oxaliplatin
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: July 23, 2012)	18
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Actual Primary Completion Date	May 2002 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Austria, Belgium, France, Germany, Israel, Slovenia, United Kingdom
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00006121
Other Study ID Numbers ICMJE	EORTC-16001-10005; EORTC-16001
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor ICMJE	European Organisation for Research and Treatment of Cancer - EORTC
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Pierre Fumoleau, MD, PhD Centre Georges Francois Leclerc
PRS Account	European Organisation for Research and Treatment of Cancer - EORTC
Verification Date	July 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP