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

Advanced Adult Primary Liver Cancer Clinical Trial

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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Adult Primary Hepatocellular Carcinoma
  • Advanced Adult Primary Liver Cancer
  • Carcinoma, Hepatocellular
  • Liver Neoplasms
  • Localized Resectable Adult Primary Liver Cancer
  • Localized Unresectable Adult Primary Liver Cancer
  • Recurrent Adult Primary Liver Cancer
Clinical Trial Details
NCT number NCT00844168
Study type Interventional
Source University of Washington
Contact
Status Completed
Phase Phase 1
Start date January 2009
View Details
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