Spots Global Cancer Trial Database for Erlotinib Hydrochloride in Preventing Liver Cancer in Patients With Cirrhosis of the Liver

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Trial Identification

Brief Title: Erlotinib Hydrochloride in Preventing Liver Cancer in Patients With Cirrhosis of the Liver

Official Title: Pilot Study of EGFR Inhibition With Erlotinib in Cirrhosis to Inhibit Fibrogenesis and Prevent Hepatocellular Carcinoma

Study ID: NCT02273362

Conditions

Cirrhosis

Hepatocellular Carcinoma

Interventions

Erlotinib

Erlotinib Hydrochloride

Laboratory Biomarker Analysis

Quality-of-Life Assessment

Study Description

Brief Summary: This pilot phase I/II trial studies the best dose of erlotinib hydrochloride and to see how well it works in preventing liver cancer in patients with scarring (cirrhosis) of the liver. Erlotinib hydrochloride may help to inhibit the development of fibrous tissue and prevent liver cancer from forming in patients with cirrhosis of the liver.

Detailed Description: PRIMARY OBJECTIVES: I. Determine the safe and minimum effective dose (MED) of daily erlotinib (erlotinib hydrochloride) that inhibits epidermal growth factor receptor (EGFR) signaling in the target organ (liver) as assessed by phosphorylated (phospho)-EGFR staining. SECONDARY OBJECTIVES: I. Determine the relationship between erlotinib dose-schedule and side effects in participants with cirrhosis. TRANSLATIONAL OBJECTIVES: I. Determine the relationship between erlotinib dose-schedule and immuno-histochemical staining pattern of phospho-ERK, proliferating cell nuclear antigen (PCNA), epidermal growth factor (EGF), and alpha smooth muscle actin (alphaSMA) in the liver. II. Determine the relationship between erlotinib dose-schedule and gene expression signature associated with prognosis in cirrhosis participants following hepatocellular carcinoma (HCC) resection. III. Determine the relationship between erlotinib dose-schedule and viral load in participants with hepatitis C virus (HCV) positive (+). IV. Determine the relationship between erlotinib dose-schedule and erlotinib plasma level on day of liver resection. OUTLINE: This is a phase I, dose-escalation/de-escalation study followed by a phase II study. Patients receive erlotinib hydrochloride orally (PO) once daily (QD) for 7 days (depending on the date of surgery, treatment range may be 5-14 days).