Clinical trial NCT00620971 (phase 2, status: completed)
Conditions: non small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: vinorelbine, cisplatin, bevacizumab, docetaxel, gemcitabine, bevacizumab, docetaxel, cisplatin, bevacizumab
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][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, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [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, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed, unresectable locally advanced (stage IIIB with pleural
             effusion) or metastatic (stage IV) non-squamous NSCLC

          -  Performance status (WHO) 0-1

          -  Adequate bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 11 g/dL), liver
             (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 2.5 UNL, ALP ≤ 5 UNL), and renal function
             (Creatinine ≤ UNL - if borderline, creatinine clearance should be ≥ 60 mL/min)

          -  No previous chemotherapy or immunotherapy for advanced/metastatic NSCLC is allowed

             --Previous radiotherapy is allowed provided that the measurable lesions are outside
             the radiation fields

          -  Measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 X 10
             mm

          -  Patient able to take oral medication

          -  Absence of active CNS disease

          -  Paraffin embedded sample of primary or metastatic tumor diagnostic specimen must be
             available

          -  Patients must be able to understand the nature of this study and give written informed
             consent

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  Women of child-bearing age unable or unwilling to take effective contraceptive
             measures

          -  Active CNS disease, brain metastases, or leptomeningeal involvement

          -  Symptomatic neuropathy > grade1 according to the NCI CTCAE (version 3.0)

          -  Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial
             infarction within the previous 4 months, LVEF < normal, uncontrolled hypertension,
             ventricular arrhythmia), anticoagulation treatment or thrombotic event within the
             previous 6 months

          -  Active infection, requiring IV antibiotic treatment, within the previous 2 weeks

          -  Long-term oxygen therapy

          -  Second primary malignancy, except for non-melanoma skin cancer and in situ cervical
             cancer

          -  Radiotherapy within the previous 4 weeks

          -  Previous radiotherapy to the only measurable lesion

          -  Concurrent treatment with other anti-cancer drug

          -  Uncontrolled hypercalcemia

          -  Known allergy to drugs with similar chemical structure to study drugs. Concurrent
             corticosteroids, except for chronic therapy with methylprednisolone ≤ 20 mgr daily (or
             equivalent) for more than one month