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

Breast Cancer Clinical Trial

Official title:

Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00006121
• Other study ID #: EORTC-16001-10005
• Secondary ID: EORTC-16001
• Status: Terminated
• Phase: Phase 2
• First received: August 3, 2000
• Last updated: July 23, 2012
• Start date: May 2000

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. primary completion date: May 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• oxaliplatin

Locations

Country	Name	City	State
Austria	Kaiser Franz Josef Hospital	Vienna (Wien)
Belgium	Institut Jules Bordet	Brussels (Bruxelles)
France	CHU de la Timone	Marseille
France	CRLCC Nantes - Atlantique	Nantes-Saint Herblain
France	Centre Eugene Marquis	Rennes
Germany	Universitats-Krankenhaus Eppendorf	Hamburg
Israel	Rambam Medical Center	Haifa
Israel	Schneider Children's Medical Center of Israel	Petah-Tikva
Slovenia	Institute of Oncology, Ljubljana	Ljubljana
United Kingdom	Beatson Oncology Centre	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Israel,  Slovenia,  United Kingdom,