Sorafenib in Combination With Capecitabine for Patients With Measurable Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC), also known as primary liver cancer, is the most common form
of liver cancer and is responsible for 80 percent of the primary malignant liver tumors in
adults. It is the fifth most common cancer in the world. HCC disproportionately affects
men, with four times as many men developing the disease as women. In 2002, approximately
626,000 cases of HCC were reported worldwide (15,000 in the United States and 53,600 in
Europe), and more than 600,000 deaths (about 13,000 Americans and 57,000 Europeans) due to
HCC were reported. The five-year relative survival rate is about seven percent.
The Gem-Ox regimen has been used in the treatment of pancreatic cancer with encouraging
results. Preliminary results of the Gem-Ox combination have been encouraging as well.Based
on these observations the possibility of adding bevacizumab, a monoclonal antibody against
VEGF, is being studied by other investigators. However, the combination of GEM-OX with
bevacizumab is unlikely to be tolerated by HCC patients with Child-Pugh class B and C liver
cirrhosis especially those with significant thrombocytopenia.It would seem therefore that
the agents that could be tolerated by cirrhotic patients with advanced HCC would include
capecitabine, erlotinib and sorafenib. We propose this phase II trial of sorafenib +
capecitabine combination in patients with HCC and advanced liver cirrhosis who have a
platelet count of ≥ 40,000 and a Child-Pugh (C-P) class A-and B liver cirrhosis with a life
expectancy of ≥16 weeks.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of the study is to evaluate safety and tolerability of the study treatment regimen. The analyses will be descriptive and no formal hypotheses testing will be performed.
6 months
Yes
Yehuda Z. Patt, MD
Principal Investigator
University of New Mexico Cancer Center
United States: Food and Drug Administration
INST 0820
NCT01032850
September 2009
June 2014
Name | Location |
---|---|
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
University of New Mexico Cancer Center @ Lovelace Medical Center | Albuquerque, New Mexico 87102 |
Cancer Center at Presbyterian Hospital | Albuquerque, New Mexico 87110 |