Sorafenib, Cisplatin, and Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Inclusion 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