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

Stopped early · Phase 2

Conditions studied: Adult Hepatocellular Carcinoma, Advanced Adult Hepatocellular Carcinoma, Localized Non-Resectable Adult Liver Carcinoma, Recurrent Adult Liver Carcinoma

In brief

This phase II trial is studying how well MK2206 works in treating patients with advanced liver cancer that did not respond to previous therapy. MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT01239355

Run by

National Cancer Institute (NCI)

People needed

15

Starts

2010-12-01

Expected to finish

2013-02-01

Last updated by the study team

2015-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unresectable or metastatic HCC for which standard curative measures do not exist
• The diagnosis of hepatocellular carcinoma should be based on at least one of the following:
• The presence of one or more liver lesions, measuring >= 2 cm, with characteristic arterial enhancement and venous washout in the setting of liver cirrhosis and/or hepatitis B or C infection
• The presence of liver lesion(s) with AFP >= 400
• Tissue confirmation in the absence of either or both of the above
• Tissue availability is desired and will be sought, but tissue availability is not mandated for accrual to the study
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension, and that has not been the target of local or regional therapy including transarterial chemoembolization, intra-arterial chemotherapy, ethanol, or RFA ablation
• One prior line of systemic anti-angiogenic therapy is required; this type of therapy includes, but is not restricted to, sorafenib, bevacizumab, sunitinib, or brivanib given as single agents or in combination with other agents
• No clinically evident ascites (minimal, medically controlled ascites detectable on imaging studies only is allowed)
• No Child-Pugh C cirrhosis or Child-Pugh B cirrhosis with more than 7 points
• No fibrolamellar carcinoma or any mixed variants of HCC with dominant fibrolamellar histology
• Patients with known brain metastases should be excluded from this clinical trial
• ECOG 0-1
• Life expectancy of greater than 3 months
• Leukocytes >= 3,000/mcL
• Absolute neutrophil count > 1,000 mcL
• Platelets >= 70,000/mcL
• Total bilirubin =< 1.5 institutional upper limit of normal
• AST (SGOT)/ALT (SGPT) < 5 x institutional upper limit of normal
• Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min
• Serum albumin >= 2.8 g/dL
• Not pregnant or nursing
• Fertile patients must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
• Must agree to collection of correlative blood samples during the study
• No patients unable to swallow pills or diagnosed with a gastrointestinal disorder that is likely to interfere with the absorption of MK-2206 or with the patient's ability to take regular oral medication

Where it is running

• Tower Cancer Research Foundation — Beverly Hills, California, United States
• City of Hope Medical Center — Duarte, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• NorthShore University HealthSystem-Evanston Hospital — Evanston, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Joliet Oncology-Hematology Associates Limited — Joliet, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Illinois CancerCare-Peoria — Peoria, Illinois, United States
• Central Illinois Hematology Oncology Center — Springfield, Illinois, United States
• Southern Illinois University — Springfield, Illinois, United States
• Fort Wayne Medical Oncology and Hematology Inc-Parkview — Fort Wayne, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Oncology Care Associates PLLC — Saint Joseph, Michigan, United States
• Saint John's Mercy Medical Center — St Louis, Missouri, United States
• Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States
• Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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