Pemetrexed Disodium and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors

Inclusion Criteria:

• Advanced solid tumor malignancy for which there is no potentially curative treatment
• Performance status Eastern Cooperative Oncology Group (ECOG) equal or less than 2
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 5 x upper institutional limit (ULN)
• Total bilirubin =< 1.5 ULN
• Creatinine clearance (CrCl) >= 45 as measured by the standard Cockroft-Gault equation
• Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 (if not due to anticoagulants)
• White blood cell count (WBC) >= 3.0
• Absolute neutrophil count (ANC) >= 1.5
• Platelets >= 80,000
• Hemoglobin (Hgb) >= 8.5
• Prior toxicities are allowed as long as they are stable and would not interfere with study drug toxicity assessment
• Measurable or evaluable disease by Response Evaluation Criteria In Solid Tumors (RECIST) (v 1.1) criteria
• Ability to understand and the willingness to sign a written informed consent document; a signed informed consent must be obtained prior to any study specific procedures
• Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment; women of childbearing potential and men must agree to use a medically accepted form of birth control for the duration of study participation; men must agree to use a medically accepted form of birth control for 2 months following completion of study treatment

Exclusion Criteria:

• Any investigational agent within 4 weeks or 5 half-lives, whichever is longer, of first dose of study treatment
• Unwillingness or inability to take folic acid, vitamin B12 supplementation, or dexamethasone
• Known or presumed intolerance of pemetrexed or sorafenib; unable to swallow medication; suspected malabsorption
• Active illicit substance or alcohol abuse
• Contraindication to antiangiogenic agents, including:
• Pulmonary hemorrhage/bleeding event >= Grade 2 within 4 weeks or less prior to the first dose of study drug
• Any other hemorrhage/bleeding event >= Grade 3 within 4 weeks or less prior to the first dose of study drug
• Serious non-healing wound, ulcer, or bone fracture
• Thrombolic or embolic events such as a myocardial infarction, cerebrovascular accident including transient ischemic attacks within the past 6 months
• Major cardiac dysfunction, such as uncontrolled angina, congestive heart failure with New York Heart Association (NYHA) class III or higher, ventricular arrhythmias requiring anti-arrhythmic therapy
• Systolic blood pressure > 160 mmHg or diastolic pressure > 100 mmHg despite optimal medical management
• Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5 day period
• Serious uncontrolled infection > Common Terminology Criteria for Adverse Events (CTCAE) (v 4) grade 2
• Uncontrolled metastatic brain disease
• Other condition(s) that in the opinion of the investigator might compromise the objectives of the study