Background:
Sorafenib is a drug that has been approved to treat kidney and liver cancer (hepatocellular
carcinoma, or HCC) and has been shown to prolong survival in patients with HCC. It works by
slowing the spread of cancer cells, but it does not fully prevent the cancer from growing
again. Researchers are interested in combining sorafenib with the experimental drug TRC105,
which has been designed to block the growth of blood vessels that lead to tumor growth, in
order to determine whether this drug combination stops tumor growth and reduces tumor size
better than sorafenib alone.
Objectives:
To determine the safety and effectiveness of the combination of sorafenib and TRC105 as a
treatment for hepatocellular cancer that has not responded to other treatments.
Eligibility:
Individuals at least 18 years of age who have been diagnosed with hepatocellular cancer that
has not responded to other treatments, and who are not considered to be candidates for liver
transplantation. Patients cannot be receiving anticoagulant therapy with the exception of low
dose aspirin. No history of bleeding problems or peptic ulcer disease.
Design:
Participants will be screened with a full medical history and physical examination, blood and
urine tests, and tumor imaging studies. Participants will have a tumor biopsy or provide
previously collected tumor tissue for study. An examination of the esophagus to look for
problems with blood vessels will be completed in patients with a history of cirrhosis.
Participants will receive sorafenib tablets twice every day, in the morning and at night,
with a full glass of water.
Participants will receive TRC 105 infusions once every two weeks on days 1 and 15 of a 28 day
cycle.
At each visit during the first cycle, participants will have a physical examination and blood
tests. Participants will continue to have blood tests and a urine test every cycle to monitor
the effects of treatment, including tests of kidney function. Participants will have imaging
studies after every two cycles to evaluate the results of treatment, and may also provide
tumor samples for study.
Treatment will continue as long as the tumor does not grow and side effects remain tolerable.