Clinical Trials

Inclusion Criteria:

• Histologic or cytologic confirmation of lung cancer (squamous, Rasmutated adenocarcinoma or small cell lung cancer) Patients must have received at least one course of chemotherapy consisting of a platinum doublet and must have no acceptable standard treatment options.
• Prior radiation therapy is permitted as long as:
  • Recovered from the toxic effects of radiation treatment before study entry, except for alopecia
• Absolute neutrophil count (ANC) ≥ 1500 uL
• Platelets (PLT) ≥ 100,000 uL
• Hemoglobin (Hgb) ≥ 9 g/dL
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or direct bilirubin ≤ ULN
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) ≤ 3 x ULN or SGOT (AST) and SGPT (ALT) ≤ 5 x ULN is acceptable if liver has tumor involvement
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2
• Negative serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
• Ability to provide informed consent
• Life expectancy ≥ 12 weeks
• Willing to return to Mayo Clinic enrolling institution for follow-up
• Willing to provide tissue and blood samples for correlative research purposes

Exclusion Criteria:

Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:

• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception Symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases or seizure disorder; NOTE: Patients with treated CNS metastases without evidence of progression and without uncontrolled symptoms or need for steroids may enroll Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded because of possible pharmacokinetic interactions with oral investigational agents Unwilling or unable to, comply with the protocol

Any of the following prior therapies:

• Radiation to ≥ 25% of bone marrow
• Major surgery (i.e., laparotomy), open biopsy, or significant traumatic injury ≤ 4 weeks prior to registration; minor surgery ≤ 2 weeks prior to registration; insertion of a vascular access device is not considered major or minor surgery in this regard

Any of the following concurrent severe and/or uncontrolled medical conditions:

• Hypertension, labile hypertension, or history of poor compliance with antihypertensive medication
• Angina pectoris
• History of congestive heart failure ≤ 84 days (3 months), unless ejection fraction > 40%
• Myocardial infarction ≤ 168 days (6 months) prior to registration
• Cardiac arrhythmia
• Poorly controlled diabetes
• Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
• Active or recent history of hemoptysis; if hemoptysis has resolved with measures such as palliative radiation therapy (e.g. 3000 cGy over 10 fractions), arteriographic embolization or endobronchial interventions (e.g. photodynamic therapy, brachytherapy), etc. for > 14 days, patients may be considered for participation in this study
• > grade 2 hypertriglyceridemia
• ≥ grade 2 hypercholesterolemia
• Any illness that in the opinion of the investigator would compromise the ability of the patient to participate safely in the clinical trial.