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

NCT ID: NCT00006121

Last Updated: 2012-07-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-05-31

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.

Conditions

Breast Cancer

Keywords

stage III breast cancer; stage IV breast cancer; recurrent breast cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

oxaliplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Fumoleau, MD, PhD

Role: STUDY_CHAIR

Centre Georges Francois Leclerc

Locations

Kaiser Franz Josef Hospital

Vienna (Wien), , Austria

Institut Jules Bordet

Brussels (Bruxelles), , Belgium

CHU de la Timone

Marseille, , France

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, , France

Centre Eugene Marquis

Rennes, , France

Universitats-Krankenhaus Eppendorf

Hamburg, , Germany

Rambam Medical Center

Haifa, , Israel

Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Institute of Oncology, Ljubljana

Ljubljana, , Slovenia

Beatson Oncology Centre

Glasgow, Scotland, United Kingdom

Countries

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

Other Identifiers

EORTC-16001

Identifier Type: -

Identifier Source: secondary_id

EORTC-16001-10005

Identifier Type: -

Identifier Source: org_study_id