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Sorafenib and Vorinostat in Treating Patients With Advanced Liver Cancer

2014-08-27 03:15:41 | BioPortfolio

Summary

Rationale: Sorafenib tosylate and vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Giving sorafenib tosylate together with vorinostat may kill more tumor cells.

Purpose: This phase I trial is studying the side effects and best dose of vorinostat when given together with sorafenib tosylate in treating patients with advanced liver cancer (hepatocellular carcinoma).

Description

Primary Objectives:

I. To determine doses for the combination of sorafenib and vorinostat appropriate for phase II study in HCC.

Secondary Objectives:

I. To evaluate the safety, tolerance, and toxicity of the combination of sorafenib and vorinostat in patients with HCC.

II. To observe antitumor effects of the combination.

Outline: This is a dose-escalation study of vorinostat. Patients receive oral sorafenib tosylate twice daily for 3 weeks and oral vorinostat once daily, 5 days a week, for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

Study Design

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

Conditions

Liver Cancer

Intervention

sorafenib tosylate, vorinostat

Location

Virginia Commonwealth University
Richmond
Virginia
United States
23298

Status

Not yet recruiting

Source

Virginia Commonwealth University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:41-0400

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Medical and Biotech [MESH] Definitions

Tumors or cancer of the LIVER.

A cancer registry mandated under the National Cancer Act of 1971 to operate and maintain a population-based cancer reporting system, reporting periodically estimates of cancer incidence and mortality in the United States. The Surveillance, Epidemiology, and End Results (SEER) Program is a continuing project of the National Cancer Institute of the National Institutes of Health. Among its goals, in addition to assembling and reporting cancer statistics, are the monitoring of annual cancer incident trends and the promoting of studies designed to identify factors amenable to cancer control interventions. (From National Cancer Institute, NIH Publication No. 91-3074, October 1990)

A 4-hydroxylated metabolite of AFLATOXIN B1, one of the MYCOTOXINS from ASPERGILLUS tainted food. It is associated with LIVER damage and cancer resulting from its P450 activation to the epoxide which alkylates DNA. Toxicity depends on the balance of liver enzymes that activate it (CYTOCHROME P-450) and others that detoxify it (GLUTATHIONE S TRANSFERASE) (Pharmac Ther 50.443 1991). Primates & rat are sensitive while mouse and hamster are tolerant (Canc Res 29.236 1969).

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Sudden liver failure in the presence of underlying compensated chronic LIVER DISEASE (e.g., LIVER CIRRHOSIS; HEPATITIS; and liver injury and failure) due to a precipitating acute hepatic insult.

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