This research study is a Phase II clinical trial. Phase II clinical trials test the
effectiveness of an investigational combination of drugs to learn whether the drug
combination works in treating a specific cancer. "Investigational" means that the modified
FOLFOX and sorafenib combination is still being studied and that research doctors are trying
find out more about it-such as the safest dose to use, the side effects it may cause, and if
the combination is effective for treating different types of cancer. It also means that the
FDA has not yet approved the modified FOLFOX and sorafenib combination that will be used in
this study for liver cancer.
FOLFOX is a combination of three drugs: folinic acid (leucovorin), fluorouracil (5-FU), and
oxaliplatin. The dosage amounts for some of these FDA approved drugs will be modified
slightly in this study. The FOLFOX combination is approved by the FDA and is a standard
treatment of colorectal cancer. However, it is not approved for the treatment of liver
cancer.
Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of
liver cancer. It is also currently being tested in various other cancers. Sorafenib works by
slowing down and/or stopping the development of new cancer cells and new blood vessels. By
slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed
that sorafenib prevents or slows down the growth of tumors.
In this research study, sorafenib, the standard treatment, is being combined with modified
FOLFOX, which has shown some antitumor activity in liver cancer.