Sorafenib in Treating Non-Smokers or Former Light Smokers With Relapsed or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: sorafenib
Intervention description: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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.
    

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