Clinical trial NCT00049660 (phase 2/phase 3, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: capecitabine, vinorelbine tartrate
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
Reason stopped: 
    low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed breast cancer

          -  Metastatic disease

          -  Prior treatment with taxanes in the metastatic, adjuvant, or neoadjuvant setting

               -  Taxane-resistant disease allowed regardless of duration of prior therapy NOTE:
                  Resistant disease defined as progression during or within 12 weeks after taxane
                  therapy for metastatic disease or a disease-free interval of less than 12 months
                  after neoadjuvant or adjuvant therapy with a taxane

               -  Taxane-sensitive disease allowed if at least 4 prior courses were received NOTE:
                  Sensitive disease defined as progression occurring more than 12 weeks after
                  taxane therapy for metastatic disease or more than 12 months after neoadjuvant or
                  adjuvant therapy with a taxane

          -  Prior treatment with anthracyclines for metastatic disease or as adjuvant treatment OR
             medical contraindication to treatment with anthracyclines

          -  At least one unidimensionally measurable lesion (phase II study)

          -  No CNS metastases

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Sex

          -  Female

        Menopausal status

          -  Not specified

        Performance status

          -  Karnofsky 70-100%

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Bilirubin no greater than 1.25 times upper limit of normal (ULN)

          -  Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)

        Renal

          -  Creatinine clearance greater than 50 mL/min

        Cardiovascular

          -  No symptomatic ventricular arrhythmias

          -  No clinically significant congestive heart failure

          -  No clinical or ECG evidence of myocardial infarction within the past 12 months

          -  No significant coronary artery disease

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No prior malignancy within the past 5 years except contralateral breast cancer,
             nonmelanoma skin cancer, and adequately treated carcinoma in situ of the cervix

          -  No known or prior sensitivity to fluoropyrimidines, including fluorouracil

          -  No pre-existing grade 2 or greater neurotoxicity

          -  No known malabsorption or upper gastrointestinal abnormalities that would affect
             absorption of study drug

          -  No psychological, familial, sociological, or geographical condition that would
             preclude study compliance

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent biologic therapy

        Chemotherapy

          -  See Disease Characteristics

          -  No more than 2 prior chemotherapy lines for metastatic disease

          -  No prior capecitabine, vinca alkaloids, or continuous fluorouracil

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  Prior hormonal therapy allowed

          -  No concurrent hormonal therapy

        Radiotherapy

          -  No concurrent radiotherapy

        Surgery

          -  Not specified

        Other

          -  Bisphosphonate therapy for treatment and prevention of bony metastases allowed if
             initiated prior to study

          -  No other concurrent investigational treatment

          -  No concurrent brivudine with capecitabine