MK2206 in Treating Patients With Advanced Liver Cancer That Did Not Respond to Previous Therapy

Exclusion Criteria

• •Baseline QTcF \> 450 msec (male) or QTcF\> 470 msec (female) will exclude patients from entry on study
• •Patients with hepatitis B infection, defined by a positive hepatitis B surface antigen test, should be on suppressive anti-viral therapy
• •* Only the following anti-viral therapies are allowed while a patient is on study: tenofovir disoproxil fumarate and entecavir
• •* Patients with hypothyroidism must be on a stable dose of thyroid replacement and be clinically euthyroid
• •No esophageal or gastric variceal bleeding within the last 6 months
• •* Patients with prior history of variceal bleeding must have had an upper endoscopy (EGD) with appropriate treatment of varices within 6 months prior to study entry
• •No uncontrolled intercurrent illness including, but not limited to:
• •* Ongoing or active infection
• •* Symptomatic congestive heart failure
• •* Unstable angina pectoris
• •* Cardiac arrhythmia
• •* Psychiatric illness/social situations that would limit compliance with study requirements
• •None of the following:
• •* Uncontrolled hypertension (systolic BP \> 150 or diastolic BP \> 100 on two occasions within two weeks of beginning therapy on this protocol)
• •* Myocardial infarction within 6 months
• •* NYHA class \> II
• •* Clinically significant bradycardia related to underlying cardiac disease
• •* Clinically significant bundle branch block related to underlying cardiac disease
• •No patients with second primary cancer (except adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors including lymphomas without bone marrow involvement curatively treated with no evidence of disease for ≥ 5 years)
• •* The exception to this criterion is prostate cancer treated definitively with surgery and/or radiation with normal PSA and no clinical evidence of residual or recurrent prostate cancer
• •HIV-positive patients on combination antiretroviral therapy are ineligible
• •No history of allergic reactions attributed to compounds of similar chemical orbiologic composition to MK-2206 or other agents used in the study
• •No medications that cause QTc interval prolongation
• •Any number of prior regional therapies with transarterial chemoembolization, intra-arterial chemotherapy, or ablative therapy is allowed
• •* No more than 1 prior line of systemic therapy for advanced and/or unresectable disease
• •No patients who have had anti-angiogenic therapy, chemotherapy, radiotherapy or regional therapy (such as transarterial chemoembolization, intra-arterial chemotherapy) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• •* Localized radiation for palliation (i.e., bony metastasis, etc.) given for \< 3 days is allowed before therapy and is not subject to the 4-week waiting requirement
• •* Local ablative therapy such as radiofrequency ablation or cryotherapy must have been completed more than 2 weeks prior to study entry
• •Patients may not be receiving any other investigational or non-investigational agents or therapies directed at treating their hepatocellular carcinoma
• •Patients may not be receiving any other investigational agents for any condition
• •Patients receiving any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible