Clinical trial NCT00227708 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: 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 or cytologically confirmed non-small cell lung cancer, including
             adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or combination of these
             histologies

               -  Stage IIIB (i.e., pleural T4) disease

               -  Stage IV disease

               -  Recurrent disease after prior surgery or radiotherapy allowed provided disease is
                  in an area that was not previously irradiated

          -  Measurable disease by CT scan or MRI

          -  No symptomatic brain metastasis

          -  Activity of Daily Living Scale score ≥ 4

          -  Instrumental Autonomy of Daily Living Scale score ≥ 4

        PATIENT CHARACTERISTICS:

        Age

          -  70 and over

        Performance status

          -  Not specified

        Life expectancy

          -  More than 3 months

        Hematopoietic

          -  Neutrophil count > 1,500/mm^3

          -  Platelet count > 100,000/mm^3

          -  Hemoglobin > 10 g/dL

        Hepatic

          -  Transaminases < 1.5 times normal

          -  Bilirubin normal

          -  Alkaline phosphatase < 2.5 times normal

          -  Pre-albumin > 1.5 mg/dL

        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 uncontrolled high-risk arrhythmias

        Gastrointestinal

          -  No active peptic ulcer

          -  No inflammatory bowel disease

        Neurologic

          -  No history of dementia or seizures that would preclude giving informed consent

          -  No peripheral neuropathy ≥ grade 2

          -  No history of significant neurologic disorders

        Immunologic

          -  No history of hypersensitivity to the study drug or drugs formulated with polysorbate
             80

          -  No active uncontrolled infection

        Other

          -  No history of psychotic disorders

          -  No uncontrolled diabetes mellitus

          -  No absolute contraindication to corticosteroid use

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

          -  No geriatric depression scale score ≥ 12/15

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

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy for stage IIIB or IV non-small cell lung cancer

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  No concurrent chronic treatment with corticosteroids except low-dose (i.e.,
             methylprednisolone ≤ 20 mg/day or equivalent) treatment that was initiated > 6 months
             ago

        Radiotherapy

          -  See Disease Characteristics

        Surgery

          -  See Disease Characteristics

        Other

          -  More than 30 days since prior active participation in another therapeutic clinical
             trial

          -  No other concurrent anticancer therapy

          -  No other concurrent investigational drugs