Clinical trial NCT00006121 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: oxaliplatin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    low accrual
  
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