Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy

Inclusion Criteria:

* Histologically or cytologically documented cancer; diagnosis of hepatocellular carcinoma may be made by characteristic radiographic and/or AFP findings 33;
* Intended treatment with, or currently being treated by anti-cancer chemotherapy in the adjuvant or advanced setting;
* Age 18 to 79;
* Adequate renal function (serum creatinine levels \<1.5 mg/dL \[males\], \<1.4 mg/dL \[females\]). If a subject does not meet these criteria, but does have an estimated creatinine clearance \>= 60 ml/min using the Cockroft-Gault calculation, they will be allowed. The Cockroft-Gault formula is CrCl = (140-age) x weight(kg)÷(Cr x72), where CrCl = estimated creatinine clearance and Cr is plasma creatinine in mg/dL;
* Adequate hepatic parameters, including aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, and alkaline phosphatase levels ≤ 2.5 x ULN;
* Must anticipate receiving at least 3 cycles (or treatment periods of at least 3-weeks) of chemotherapy;
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* Current use of metformin (within 1 week of start of chemotherapy regimen to be assessed);
* Patients with type 2 diabetes are allowed, however they will be excluded if there is intent to use metformin for treatment of diabetes during the course of the study;
* Undergoing chemotherapy treatment concurrent with radiation therapy;
* Undergoing chemotherapy in a neoadjuvant setting prior to potentially curative surgery;
* Renal disease or renal dysfunction not meeting inclusion criteria;
* Significant medical conditions such as cardiovascular collapse (shock), acute myocardial infarction, septicemia, acute or chronic metabolic acidosis;
* History of, or states associated with, lactic acidosis such as shock or pulmonary insufficiency, alcoholism (acute or chronic), conditions associated with hypoxemia and pancreatitis;
* Severe dehydration;
* Clinical or laboratory evidence of hepatic disease;
* Congestive heart failure requiring pharmacologic treatment, or unstable or acute congestive heart failure;
* Known hypersensitivity to metformin hydrochloride;
* Pregnant or lactating women (serum pregnancy test will be performed for all women of child-bearing potential);
* Psychiatric illness or social situation that would limit compliance with study requirements and/or obscure results