Phase II Trial of Intrahepatic Artery Chemotherapy With Nexavar in Hepatocellular Carcinoma Patients
OBJECTIVES:
Primary
- To assess the safety of intrahepatic arterial infusion of cisplatin or carboplatin in
combination with sorafenib tosylate in patients with unresectable hepatocellular
carcinoma.
Secondary
- To assess the time to tumor progression in patients treated with this regimen.
- To assess the overall and progression-free survival of patients treated with this
regimen.
OUTLINE: Patients receive intrahepatic arterial infusion of cisplatin or carboplatin over
30-45 minutes on day 1 and oral sorafenib tosylate twice daily on days 8-35. Treatment
repeats every 42 days for up to 12 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety
4 years
Yes
Lynn G. Feun, MD
Principal Investigator
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
EPROST-20080793
NCT00875615
December 2008
June 2012
Name | Location |
---|---|
University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |