Clinical trial NCT00006121: Oxaliplatin in Treating Women With Advanced or Metastatic Breast Cancer That Has Not Responded to Previous Chemotherapy
Official title: Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage III breast cancer
stage IV breast cancer
recurrent breast cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-10-08
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna (Wien)
country: Austria
facility: Kaiser Franz Josef Hospital
city: Brussels (Bruxelles)
country: Belgium
facility: Institut Jules Bordet
city: Marseille
country: France
facility: CHU de la Timone
city: Nantes-Saint Herblain
country: France
facility: CRLCC Nantes - Atlantique
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Hamburg
country: Germany
facility: Universitats-Krankenhaus Eppendorf
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Petah-Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
city: Ljubljana
country: Slovenia
facility: Institute of Oncology, Ljubljana
city: Glasgow
country: United Kingdom
facility: Beatson Oncology Centre
state: Scotland
Study officials:
affiliation: Centre Georges Francois Leclerc
name: Pierre Fumoleau, MD, PhD
role: STUDY_CHAIR
References: