• 1-year progression-free survival [ Designated as safety issue: No ]
  
• 1-year overall survival [ Designated as safety issue: No ]
  
• Response rate [ Designated as safety issue: No ]
  
• Safety [ Designated as safety issue: Yes ]
  

OBJECTIVES:

• To evaluate the 1-year progression-free survival of patients with extensive-stage small cell lung cancer treated with sorafenib tosylate in combination with cisplatin and etoposide.
• To evaluate the 1-year overall survival and response rate in these patients.
• To evaluate the safety of these drugs in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral sorafenib tosylate twice daily beginning on day 1 of course 1 and continuing for up to 1 year in the absence of disease progression or unacceptable toxicity.

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