Clinical trial NCT00104624 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: docetaxel
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    toxicity issues
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the breast

               -  Metastatic disease

          -  Measurable disease by CT scan or MRI

          -  Requires first-line chemotherapy for metastatic disease

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age

          -  70 and over

        Sex

          -  Female

        Menopausal status

          -  Not specified

        Performance status

          -  Meets both of the following criteria:

               -  Lawton's Instrumental Activities of Daily Living score ≥ 4

               -  Katz's Activities of Daily Living score ≥ 4

        Life expectancy

          -  More than 3 months

        Hematopoietic

          -  Hemoglobin > 10 g/dL

          -  Neutrophil count > 1,500/mm^3

          -  Platelet count > 100,000/mm^3

        Hepatic

          -  ALT and AST < 1.5 times normal

          -  Bilirubin normal

          -  Alkaline phosphatase < 2.5 times normal

        Renal

          -  Creatinine clearance > 30 mL/min

        Cardiovascular

          -  No congestive heart failure

          -  No unstable angina pectoris

          -  No myocardial infarction within the past year

          -  No uncontrolled hypertension

          -  No high-risk uncontrolled arrhythmias

        Other

          -  Geriatric Depression Score < 12

          -  No active uncontrolled infection

          -  No active peptic ulcer

          -  No uncontrolled diabetes mellitus

          -  No inflammatory bowel disease

          -  No history of hypersensitivity to docetaxel or drugs formulated with polysorbate 80

          -  No history of significant neurologic or psychiatric disorders, including psychotic
             disorders, dementia, or seizures, that would preclude giving informed consent

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

          -  No definite contraindication to corticosteroids

          -  No other serious illness or medical condition

          -  No other malignancy within the past 5 years except basal cell skin cancer or carcinoma
             in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior or concurrent trastuzumab (Herceptin^®)

        Chemotherapy

          -  Prior neoadjuvant or adjuvant chemotherapy for breast cancer allowed

          -  More than 2 years since prior docetaxel or paclitaxel

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  No more than 1 prior hormonal therapy regimen for metastatic disease

          -  At least 10 days since prior hormonal therapy

          -  No concurrent hormonal therapy

          -  No concurrent chronic corticosteroids

               -  Concurrent low-dose corticosteroids (≤ 20 mg/day of methylprednisolone or
                  equivalent) allowed provided treatment was initiated > 6 months before study
                  entry

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified

        Other

          -  More than 30 days since prior active treatment on another clinical trial

          -  Concurrent bisphosphonates allowed for bone metastases, osteoporosis, or osteopenia

          -  No other concurrent anticancer therapy

          -  No other concurrent investigational drugs