Spots Global Cancer Trial Database for Sorafenib Tosylate in Treating Patients With Liver Cancer Who Have Undergone a Liver Transplant

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Trial Identification

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

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

Study ID: NCT00844168

Conditions

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

Interventions

sorafenib tosylate

laboratory biomarker analysis

Study Description

Brief 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.