Clinical trial NCT00118131 (phase 2, status: terminated)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: cisplatin, docetaxel
SMILES: [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, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed non-small cell lung cancer, meeting 1 of the
             following stage criteria:

               -  Stage IIIB disease with malignant pericardial or malignant pleural effusions, as
                  indicated by 1 of the following:

                    -  Positive cytology

                    -  Exudative effusion AND lactic dehydrogenase (LDH) > 200 IU with
                       effusion/serum LDH ratio ≥ 0.6

               -  Stage IV disease

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

          -  Brain metastases allowed provided they have been irradiated AND are radiographically
             stable for ≥ 28 days after the completion of radiotherapy

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  At least 12 weeks

        Hematopoietic

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

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 8.0 g/dL

        Hepatic

          -  AST and ALT normal

          -  Bilirubin normal

        Renal

          -  Creatinine clearance ≥ 50 mL/min

        Immunologic

          -  No known HIV positivity

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

          -  No clinically significant active infection

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception before, during, and for 4 weeks
             after completion of study treatment

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

          -  No other serious systemic disorder that would preclude study participation

          -  No other condition that would preclude study compliance

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Prior antibody-based therapy that targets growth factor pathways (e.g., epidermal
             growth factor receptor [EGFR]) allowed provided there is disease progression during
             therapy and patient has recovered

          -  No concurrent immunotherapy

          -  No concurrent prophylactic colony-stimulating factors

          -  No concurrent interleukin-11

        Chemotherapy

          -  No prior cytotoxic chemotherapy

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  No concurrent hormonal therapy for the malignancy

        Radiotherapy

          -  See Disease Characteristics

          -  More than 28 days since prior radiotherapy and recovered

          -  No prior radiotherapy to ≥ 25% of the bone marrow

          -  No prior radiotherapy to sites of measurable disease unless there is documented tumor
             progression after completion of radiotherapy

          -  No concurrent radiotherapy

        Surgery

          -  No concurrent surgery for the malignancy

        Other

          -  More than 3 weeks since prior investigational drugs

          -  Prior oral small molecule drug therapy that targets growth factor pathways (e.g.,
             EGFR) allowed provided there is disease progression during therapy and patient has
             recovered

          -  No other concurrent investigational or commercial agents or therapies for the
             malignancy