C80802 Phase III Randomized Study of Sorafenib Plus Doxorubicin versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC)
The purpose of this study is to compare overall survival (OS) of patients treated with sorafenib and doxorubicin to that of those treated with sorafenib for patients with advanced hepatocellular carcinoma.
You may be eligible to participate in this study, if you: have hepatocellular carcinoma with locally advanced or metastatic disease that is measurable; have not had prior adjuvant therapy with sorafenib or other Raf/VEGFR inhibitors; have not received prior systemic therapy for metastatic disease; do not have known CNS tumors including brain metastases; do not have significant GI bleeding events; do not take rifampin or St. John's Wort; have well controlled hypertension; do not have known history of congestive heart failure or cardiac arrhythmias; have not had a myocardial infarction within 6 months; do not have known history of serious myocardial dysfunction; do not have known history of bleeding diathesis; are not receiving combination anti-retroviral therapy for HIV; are 18 years of age or older; and are not pregnant or nursing.
Eligible participants will be randomly assigned to receive doxorubicin on day 1 of each 21-day cycle for 6 cycles or no infusion chemotherapy. All participants will take sorafenib by mouth twice a day until you can no longer tolerate the study drug or your disease worsens. All participants will be followed clinically and have imaging done every 2 cycles to monitor your disease. Your participation will in the study will last approximately 2 years.
11/26/2014 04:10 AM