Clinical trial NCT00726986 (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, sorafenib tosylate
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, CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Reason stopped: 
    extreme toxicity
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of extensive-stage small cell lung cancer

          -  No untreated brain metastases

               -  No active symptoms related to brain metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Hemoglobin ≥ 9.0 g/dL

          -  ANC ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement)

          -  Creatinine ≤ 1.5 times ULN

          -  INR < 1.5 or PT/PTT normal

          -  No history of cardiac disease, including any of the following:

               -  NYHA class III-IV congestive heart failure

               -  Unstable angina (i.e., anginal symptoms at rest)

               -  Onset of angina within the past 3 months

               -  Myocardial infarction within the past 6 months

          -  No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

          -  No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or
             diastolic BP > 90 mm Hg, despite optimal medical management

          -  No thrombolic or embolic events, such as cerebrovascular accident or transient
             ischemic attacks, within the past 6 months

          -  No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks

          -  No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks

          -  No known HIV infection or chronic hepatitis B or C infection

          -  No active clinically serious infection > CTCAE grade 2

          -  No serious non-healing wound, ulcer, or bone fracture

          -  No evidence or history of bleeding diathesis or coagulopathy

          -  No significant traumatic injury within the past 4 weeks

          -  No known or suspected allergy to sorafenib tosylate or to any other drug given during
             the study

          -  No condition that would impair the patient's ability to swallow whole pills

          -  No known malabsorption problem

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective barrier contraception

               -  Male patients must use effective contraception during and for ≥ 3 months after
                  completion of sorafenib tosylate

        PRIOR CONCURRENT THERAPY:

          -  Prior radiotherapy to the brain allowed

          -  No prior chemotherapy

          -  More than 4 weeks since prior major surgery or open biopsy

          -  No concurrent Hypericum perforatum (St. John's wort) or rifampin

          -  Concurrent anti-coagulation treatment, such as warfarin or heparin, allowed