Clinical trial NCT00074139 (phase 1, status: withdrawn)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: cyclophosphamide, docetaxel, doxorubicin hydrochloride
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
Reason stopped: 
    no patients were enrolled
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed advanced breast cancer

               -  Adjuvant setting for high-risk disease allowed

          -  No symptomatic evidence or history of brain metastases

          -  No leptomeningeal metastases

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age

          -  18 to 69

        Sex

          -  Female

        Menopausal status

          -  Not specified

        Performance status

          -  WHO 0-2 OR

          -  Karnofsky 60-100%

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Neutrophil count at least 2,000/mm^3

          -  Platelet count greater than 100,000/mm^3

          -  Hemoglobin greater than 10 g/dL

        Hepatic

          -  Bilirubin less than upper limit of normal (ULN)

          -  AST and ALT no greater than 2.5 times ULN (1.5 times ULN if alkaline phosphatase
             greater than 2.5 times ULN)

          -  Alkaline phosphatase no greater than 5 times ULN

        Renal

          -  Creatinine normal OR

          -  Creatinine clearance at least 60 mL/min

        Cardiovascular

          -  LVEF or shortening fraction greater than lower limit of normal by MUGA or
             echocardiography

          -  Cardiac function normal

          -  No congestive heart failure

          -  No unstable angina pectoris

          -  No myocardial infarction within the past year

          -  No uncontrolled hypertension

          -  No high-risk uncontrolled arrhythmia

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective nonhormonal contraception

          -  No active uncontrolled infection

          -  No active peptic ulcer

          -  No unstable diabetes mellitus

          -  No other serious illness or medical condition

          -  No contraindication to corticosteroids

          -  No pre-existing grade 2 or greater motor or sensory neurotoxicity

          -  No psychological, social, familial, or geographical reason that would preclude study
             follow-up

          -  No history of significant neurologic or psychiatric disorder (e.g., psychotic
             disorder, dementia, or seizures) that would preclude understanding and giving informed
             consent

          -  No other neoplasm within the past 10 years except curatively treated nonmelanoma skin
             cancer, carcinoma in situ of the cervix, ipsilateral ductal carcinoma in situ of the
             breast, or lobular carcinoma in situ of the breast

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  At least 6 months since prior anthracycline or taxoid (e.g., paclitaxel or docetaxel)
             therapy

          -  No prior cumulative anthracycline dose greater than 240 mg/m^2

        Endocrine therapy

          -  Concurrent corticosteroid treatment allowed provided treatment was initiated more than
             6 months before study entry and at a dose of less than 20 mg of methylprednisolone or
             equivalent

          -  No concurrent ovarian hormonal replacement therapy

        Radiotherapy

          -  Not specified

        Surgery

          -  More than 2 weeks since prior major surgery

        Other

          -  More than 30 days since prior participation in another clinical trial with any
             investigational drug or device

          -  No other concurrent experimental drugs

          -  No other concurrent systemic anticancer therapy

          -  No concurrent aminoglycoside antibiotics