sorafenib in treating non-smokers or former light smokers with relapsed or refractory stage iiib or stage iv non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. purpose: this phase ii trial is studying how well sorafenib works in treating non-smokers or former light smokers with relapsed or refractory stage iiib or stage iv non-small cell lung cancer.

objectives: primary * to determine the efficacy of sorafenib tosylate, in terms of 6-month progression-free survival rate, in non-smokers or former light smokers with relapsed or refractory stage iiib or iv non-small cell lung cancer. secondary * to determine the 1-year survival rate in patients treated with this drug. * to assess the frequency and severity of adverse events associated with this drug in these patients. * to investigate the mutational status of egfr (epidermal growth factor receptor), alk (anaplastic lymphoma kinase), ros1, and k-ras(kirsten rat sarcoma viral oncogene homolog)in archived tumor samples from these patients. outline: patients receive oral sorafenib tosylate twice daily on days 1-28. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. archived tumor tissue samples are analyzed for mutations of egfr, alk, ros1, and k-ras by pcr (polymerase chain reaction) and dna (deoxyribonucleic acid) sequencing. after completion of study treatment, patients are followed every 3 months.

Eligibility criteria:
disease characteristics: * histologically confirmed non-small cell lung cancer * stage iiib or iv disease * recurrent disease after prior surgery, chemotherapy, or radiotherapy * no squamous cell histology or mixed tumor with \> 50% squamous cells * non-smoker (smoked ≤ 100 cigarettes in lifetime) or former light smoker (smoked \> 100 cigarettes but ≤ 10 pack years and quit smoking ≥ 1 year ago) * no known brain metastasis * patients with neurological symptoms must undergo a ct scan or mri of the brain to exclude brain metastasis patient characteristics: * ecog(eastern cooperative oncology group)performance status 0-2 * anc (absolute neutrophil count)≥ 1,500/mm³ * platelet count ≥ 100,000/mm³ * alt (alanine aminotransferase test) and ast (aspartate aminotransferase test) ≤ 2.5 times upper limit of normal (uln) * alkaline phosphatase ≤ 2.5 times uln * bilirubin ≤ 1.5 mg/dl * creatinine clearance ≥ 50 ml/min * inr (international normalized ratio) \< 1.5 or pt/ptt (prothrombin time/partial thromboplastin time)normal * not pregnant or nursing * negative pregnancy test * fertile patients must use effective barrier contraception prior to, during, and for ≥ 3 months after completion of study treatment * no cardiac disease, including any of the following: * new york heart association class iii-iv congestive heart failure * unstable angina (anginal symptoms at rest) * new-onset angina within the past 3 months * myocardial infarction within the past 6 months * no cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * no uncontrolled hypertension (i.e., systolic blood pressure \[bp\] \> 150 mm hg or diastolic bp \> 90 mm hg) despite optimal medical management * no thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months * no pulmonary hemorrhage or bleeding event ≥ ctcae (common terminology criteria for adverse events)grade 2 within the past 4 weeks * no other hemorrhage or bleeding event ≥ ctcae grade 3 within the past 4 weeks * 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 known hiv infection or chronic hepatitis b or c * no other malignancy except for any of the following: * adequately treated basal cell or squamous cell skin cancer * in situ cervical cancer * other cancer from which the patient has been disease-free for ≥ 5 years with a low probability of recurrence * no condition that impairs the patient's ability to swallow whole pills * no malabsorption problems * no known or suspected allergy to sorafenib tosylate or any agent given in the course of this study * no significant traumatic injury within the past 4 weeks prior concurrent therapy: * see disease characteristics * no more than one prior systemic chemotherapy treatment for metastatic disease * prior treatment with egfr inhibitors is not considered chemotherapy * more than 4 weeks since prior major surgery or open biopsy * no prior sorafenib tosylate * no concurrent st. john's wort or rifampin * concurrent anticoagulation with warfarin or heparin allowed

Keywords: recurrent non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer