Liver Cancer Clinical Trial
Official title:
A Phase I Study of Sorafenib and Vorinostat in Advanced Hepatocellular Carcinoma
This phase I trial is studying the side effects and best dose of vorinostat when given together with sorafenib tosylate in treating patients with advanced liver cancer. Sorafenib tosylate and vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
Outline: This is a dose-escalation study of vorinostat. The purpose of this research study is
to test the safety and effectiveness of a combination of two cancer drugs, sorafenib
(Nexavar) and vorinostat (Zolinza), in advanced liver cancer (hepatocellular carcinoma).
Advanced means that the cancer has spread too far to consider surgery. Approximately 19
people will take part in this study.
After enrollment of 6 patients at sorafenib 400 mg orally twice a day and vorinostat 300 mg
orally, only 2 of the 6 patients were evaluable for DLT (no DLTs). The other 4 patients were
not evaluable for DLT because of required dose modifications. Because of this dose
modification need, Cohort A has been modified to include 2 dose levels: Dose level A-1a
(sorafenib 400 mg orally twice a day and vorinostat 200 mg orally once a day) and dose level
A1 (sorafenib 400 mg orally twice a day with vorinostat 100 mg orally once a day). The
starting dose upon reopening after approval of this version will be dose level A-1a. Dose
level A1 will only be used if dose level A-1a is not tolerable.
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