Clinical Trials Directory

Trials / Completed

CompletedNCT00844168

Sorafenib Tosylate in Treating Patients With Liver Cancer Who Have Undergone a Liver Transplant

Phase I Adjuvant Trial of Sorafenib in Hepatocellular Carcinoma Patients After Liver Transplantation

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
4 (actual)
Sponsor
University of Washington · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

PRIMARY OBJECTIVES: I. Establish the safety and toxicity profile of sorafenib administered daily to hepatocellular carcinoma (HCC) patients who have undergone orthotopic liver transplantation. SECONDARY OBJECTIVES: 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.

Conditions

Interventions

TypeNameDescription
DRUGsorafenib tosylateGiven orally
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2009-01-01
Primary completion
2010-06-01
First posted
2009-02-16
Last updated
2015-03-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00844168. Inclusion in this directory is not an endorsement.