Status:
COMPLETED
Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy
Lead Sponsor:
Tufts Medical Center
Conditions:
Cancer
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
Brief Summary
Metformin is a drug that is normally used to treat people with diabetes. New research has discovered that metformin may also kill cancer stem cells. These cancer stem cells make up only a small portio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01442870
Start Date
September 1 2011
End Date
November 1 2014
Last Update
May 9 2017
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111