Clinical trial NCT00258375 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: custirsen sodium, docetaxel
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed breast cancer

               -  Metastatic or locally advanced disease

               -  Not curable with standard therapy

          -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
             conventional techniques OR ≥ 10 mm by spiral CT scan

               -  Lesion must be outside of the previously irradiated field

                    -  If the sole site of disease is in a previously irradiated field, there must
                       be evidence of disease progression or new lesions in the irradiated field

          -  No known CNS metastases

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Sex

          -  Female

        Menopausal status

          -  Not specified

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  At least 12 weeks

        Hematopoietic

          -  Platelet count ≥ 100,000/mm^3

          -  Absolute granulocyte count ≥ 1,500/mm^3

          -  PTT, PT, and INR normal

          -  No known bleeding disorder

        Hepatic

          -  Bilirubin normal

          -  AST and ALT ≤ 1.5 times upper limit of normal (ULN)

        Renal

          -  Creatinine ≤ 1.5 times ULN

        Cardiovascular

          -  No significant cardiac dysfunction

        Immunologic

          -  No active uncontrolled infection

          -  No history of serious allergic reaction to taxanes, including paclitaxel or docetaxel

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No preexisting neuropathy ≥ grade 2

          -  No other malignancies within the past 5 years except adequately treated nonmelanoma
             skin cancer or curatively treated carcinoma in situ of the cervix

          -  No other serious medical condition or illness that would preclude study participation

          -  No significant neurological disorder that would preclude giving informed consent

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Prior trastuzumab (Herceptin^®) allowed

        Chemotherapy

          -  Recovered from prior chemotherapy

          -  At least 6 months since prior adjuvant chemotherapy (taxanes allowed)

          -  At least 4 weeks since prior chemotherapy for advanced disease

               -  No prior taxanes for advanced disease

          -  No more than 1 prior chemotherapy regimen for advanced disease

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  At least 1 week since prior hormonal therapy

        Radiotherapy

          -  See Disease Characteristics

          -  At least 4 weeks since prior radiotherapy

               -  Low-dose, nonmyelosuppressive radiotherapy allowed within 4 weeks before study
                  entry at the discretion of the investigator

          -  No prior radiotherapy ≥ 30% of functioning bone marrow

          -  No concurrent radiotherapy

        Surgery

          -  At least 3 weeks since prior major surgery and recovered (wound healing must have
             occurred)

        Other

          -  More than 4 weeks since prior investigational agents or new anticancer therapy

          -  No concurrent therapeutic anticoagulation therapy except low-dose oral anticoagulant
             therapy (i.e., 1 mg of oral warfarin once a day) or low molecular weight heparin

          -  No other concurrent investigational therapy

          -  No other concurrent cytotoxic therapy