Clinical trial NCT00021112 (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, etoposide
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, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1
Reason stopped: 
    low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed primary stage IIIB non-small cell lung
             cancer (NSCLC)

               -  T4, any N, M0 or any T, N3, M0

               -  No N3 disease due to scalene or supraclavicular lymph node involvement

          -  No primary tumors located in the lower lobe combined with contralateral upper higher
             mediastinal lymph node involvement

          -  No mixed tumor types with small cell lung cancer

          -  At least 1 unidimensionally measurable target lesion

               -  At least 20 mm by conventional techniques OR

               -  At least 10 mm by spiral CT scan

          -  No pre-existing pleural or pericardial effusion

          -  No CNS involvement by CT scan or MRI

        PATIENT CHARACTERISTICS:

        Age:

          -  18 to 75

        Performance status:

          -  WHO 0-1

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Absolute neutrophil count at least 2,000/mm^3

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

        Hepatic:

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  AST/ALT no greater than 1.5 times ULN

          -  Alkaline phosphatase no greater than 2.5 times ULN

        Renal:

          -  Creatinine no greater than 1.25 times ULN

          -  Creatinine clearance at least 60 mL/min

        Cardiovascular:

          -  No clinical evidence of superior vena cava syndrome

        Pulmonary:

          -  Postoperative FEV1 and KCO greater than 40% predicted

          -  VO2 max greater than 15 mL/min/kg (if postoperative KCO no greater than 40% predicted)

        Other:

          -  No other primary malignancy except carcinoma in situ of the cervix, adequately treated
             basal cell skin cancer, or other malignancy treated more than 5 years ago without
             recurrence (excluding melanoma, breast cancer, or hypernephroma)

          -  No active uncontrolled infection requiring IV antibiotics

          -  No pre-existing sensory neurotoxicity grade 2 or greater

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

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior immunotherapy for NSCLC

          -  No concurrent immunotherapy during induction chemoradiotherapy

          -  Concurrent colony stimulating factors allowed

        Chemotherapy:

          -  No prior chemotherapy for NSCLC

        Endocrine therapy:

          -  No concurrent anticancer hormonal agents (except corticosteroids for antiemetic
             prophylaxis) during induction chemoradiotherapy

        Radiotherapy:

          -  No prior radiotherapy for NSCLC

        Surgery:

          -  No prior surgery for NSCLC

        Other:

          -  No other concurrent anticancer drugs during induction chemoradiotherapy