Clinical trial NCT00030810 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: taxotere/cisplatin
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed, operable stage IIIB non-small cell lung cancer

               -  T4 N0-3 M0 or T1-4 N3 M0 by bronchoscopy and mediastinoscopy (required for
                  assessment of N3 disease) or CT scan or MRI of the thorax

               -  Squamous cell

               -  Adenosquamous cell

               -  Large cell

               -  Poorly differentiated

          -  No prior or concurrent metastatic disease by CT scan or MRI of the brain, bone scan,
             and abdominal ultrasound or CT scan

          -  No malignant pleural or pericardial effusion

          -  No invasion of the aorta, esophagus, myocardium, or supraclavicular nodes

        PATIENT CHARACTERISTICS:

        Age:

          -  18 to 75

        Performance status:

          -  WHO 0-1

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  WBC at least 4,000/mm^3

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

        Hepatic:

          -  Bilirubin normal

          -  AST and/or ALT no greater than 1.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase no greater than 2.5 times ULN

        Renal:

          -  Creatinine clearance at least 60 mL/min

        Cardiovascular:

          -  No unstable cardiac disease requiring treatment

          -  No congestive heart failure

          -  No angina pectoris (even if medically controlled)

          -  No significant arrhythmia

          -  No myocardial infarction within the past 3 months

        Other:

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No definite contraindications for the use of corticosteroids as premedication

          -  No preexisting grade 2 or greater peripheral neuropathy

          -  No active uncontrolled infection

          -  No uncontrolled diabetes mellitus

          -  No other prior or concurrent malignancy except non-melanomatous skin cancer or
             adequately treated carcinoma in situ of the cervix

          -  No prior significant neurologic or psychiatric disorders including psychotic
             disorders, dementia, or seizures that would preclude informed consent

          -  No other serious underlying medical condition that would preclude study participation

          -  No socioeconomic or geographical circumstances that would preclude study compliance

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  Not specified

        Endocrine therapy:

          -  No concurrent corticosteroids except as prophylactic pretreatment medication,
             treatment for acute hypersensitivity reactions, or chronic treatment (initiated more
             than 6 months ago) at low-dose (no more than 20 mg methylprednisolone or equivalent)

        Radiotherapy:

          -  No prior radiotherapy to the chest

        Surgery:

          -  See Disease Characteristics

        Other:

          -  At least 30 days since prior treatment in a clinical trial

          -  No prior cytostatic therapy

          -  No other concurrent experimental drugs