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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Terminated

CT.gov ID

NCT00006121

Collaborator

(none)

Enrollment

Locations

1.8

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: oxaliplatin	Phase 2

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

Study Type:

Interventional

Actual Enrollment :

18 participants

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2000

Actual Primary Completion Date :

May 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Franz Josef Hospital	Vienna (Wien)		Austria	A-1100
2	Institut Jules Bordet	Brussels (Bruxelles)		Belgium	1000
3	CHU de la Timone	Marseille		France	13385
4	CRLCC Nantes - Atlantique	Nantes-Saint Herblain		France	44805
5	Centre Eugene Marquis	Rennes		France	35064
6	Universitats-Krankenhaus Eppendorf	Hamburg		Germany	D-20246
7	Rambam Medical Center	Haifa		Israel	31096
8	Schneider Children's Medical Center of Israel	Petah-Tikva		Israel	49202
9	Institute of Oncology, Ljubljana	Ljubljana		Slovenia	Sl-1000
10	Beatson Oncology Centre	Glasgow	Scotland	United Kingdom	G11 6NT