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	Treatment or Intervention	Phase
stage III breast cancer stage IV breast cancer recurrent breast cancer	Procedure: chemotherapy  Drug: oxaliplatin	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the therapeutic activity of oxaliplatin in patients with advanced or metastatic breast cancer following failure of anthracycline/taxane based chemotherapy. II. Determine objective response, duration of response, and time to progression in these patients when treated with this regimen. III. Determine the acute side effects of this regimen in these patients.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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 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

--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

--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/mm3; Platelet count greater than 100,000/mm3
• 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

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

Study chairs or principal investigators

Pierre Fumoleau,  Study Chair,  EORTC New Drug Development Group   

Study ID Numbers:  CDR0000068135; EORTC-16001
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  August 3, 2000
ClinicalTrials.gov Identifier:  NCT00006121
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08