Sorafenib Tosylate in Treating Patients With Liver Cancer Who Have Undergone a Liver Transplant
This phase I trial studies the side effects and best dose of sorafenib tosylate in treating patients with liver cancer who have undergone a liver transplant. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib after liver transplant may be an effective treatment for liver cancer
Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Resectable Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Drug: sorafenib tosylate
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Adjuvant Trial of Sorafenib in Hepatocellular Carcinoma Patients After Liver Transplantation|
- Dose-limiting toxicity (DLT) as defined by the Common Terminology for Adverse Events (CTAE) version 3 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Defined as grade >= 3 nonhematologic/hematologic toxicity
|Study Start Date:||January 2009|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment (adjuvant sorafenib tosylate after liver transplant)
Patients receive sorafenib tosylate PO twice daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: sorafenib tosylate
Other Names:Other: laboratory biomarker analysis
I. Establish the safety and toxicity profile of sorafenib administered daily to hepatocellular carcinoma (HCC) patients who have undergone orthotopic liver transplantation.
I. Determine explant and allograft expression of vascular endothelial growth factor (VEGF), platelet derived growth factor receptor (PDGFR), microvessel density (CD34) and Ki67 (proliferation marker).
OUTLINE: Patients receive sorafenib tosylate orally (PO) twice daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844168
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Edward Lin||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|