Clinical trial NCT00054275 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: docetaxel, erlotinib hydrochloride
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed stage IV or recurrent adenocarcinoma of the breast

          -  Measurable disease

          -  Disease recurrence must not be within 1 year of receiving prior adjuvant docetaxel

          -  Stable brain metastases allowed

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Sex

          -  Male or female

        Menopausal status

          -  Not specified

        Performance status

          -  ECOG (Eastern Cooperative Oncology Group) 0-2 OR

          -  Karnofsky 60-100%

        Life expectancy

          -  More than 6 months

        Hematopoietic

          -  WBC(White Blood Count) at least 3,000/mm^3

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

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

          -  Hemoglobin at least 8 g/dL

        Hepatic

          -  Bilirubin normal

          -  AST(aspartate aminotransferase)/ALT(alanine aminotransferase) no greater than 2.5
             times upper limit of normal

        Renal

          -  Creatinine normal OR

          -  Creatinine clearance at least 60 mL/min

          -  No clinically significant proteinuria

          -  No significant impairment of renal function

        Cardiovascular

          -  No New York Heart Association class III or IV heart disease

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  No inadequately controlled hypertension

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective barrier contraception

          -  No prior severe hypersensitivity reaction to docetaxel or drugs formulated with
             polysorbate 80

          -  No other malignancy within the past 10 years except inactive nonmelanoma skin cancer,
             carcinoma in situ of the cervix, carcinoma in situ of the breast, or bilateral breast
             cancer

          -  No ongoing or active infection

          -  No peripheral neuropathy greater than grade 1

          -  No other concurrent uncontrolled medical condition that would preclude study
             participation

          -  No psychiatric illness or social situation that would preclude study compliance

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Prior trastuzumab (Herceptin) allowed

        Chemotherapy

          -  See Disease Characteristics

          -  No prior chemotherapy for recurrent or metastatic disease

          -  Prior adjuvant chemotherapy allowed

        Endocrine therapy

          -  Prior hormonal therapy allowed

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified

        Other

          -  No other concurrent investigational agents