Cixutumumab and Sorafenib Tosylate in Treating Patients With Advanced Liver Cancer
Summary
RATIONALE: Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with sorafenib tosylate may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of cixutumumab when given together with sorafenib tosylate in treating patients with advanced liver cancer.
Description
OBJECTIVES:
- To establish the maximum tolerated dose of cixutumumab when given together with standard doses of sorafenib tosylate in patients with advanced hepatocellular carcinoma (HCC).
- To describe the toxicity and tolerability of this regimen in these patients.
- To evaluate the impact of cixutumumab on biomarkers related to the IGF-1R/IGF pathway which is thought to be relevant to HCC progression and drug resistance.
- To obtain preliminary assessments of efficacy of this regimen, in terms of progression-free survival and objective response rate.
OUTLINE: This is a multicenter, dose-escalation study of cixutumumab followed by an extended accrual phase in which patients are treated at the maximum-tolerated dose.
Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22 and oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for correlative biomarker studies.
After completion of study therapy, patients are followed up periodically.
Study Design
Masking: Open Label, Primary Purpose: Treatment
Conditions
Liver Cancer
Intervention
cixutumumab, sorafenib tosylate, laboratory biomarker analysis
Location
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles
California
United States
90089-9181
Status
Recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01008566
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Choline Deficiency
A condition produced by a deficiency of CHOLINE in animals. Choline is known as a lipotropic agent because it has been shown to promote the transport of excess fat from the liver under certain conditions in laboratory animals. Combined deficiency of choline (included in the B vitamin complex) and all other methyl group donors causes liver cirrhosis in some animals. Unlike compounds normally considered as vitamins, choline does not serve as a cofactor in enzymatic reactions. (From Saunders Dictionary & Encyclopedia of Laboratory Medicine and Technology, 1984)
Liver Neoplasms
Tumors or cancer of the LIVER.
Biotechnology
Body of knowledge related to the use of organisms, cells or cell-derived constituents for the purpose of developing products which are technically, scientifically and clinically useful. Alteration of biologic function at the molecular level (i.e., GENETIC ENGINEERING) is a central focus; laboratory methods used include TRANSFECTION and CLONING technologies, sequence and structure analysis algorithms, computer databases, and gene and protein structure function analysis and prediction.
Prostatitis
Infiltration of inflammatory cells into the parenchyma of PROSTATE. The subtypes are classified by their varied laboratory analysis, clinical presentation and response to treatment.
Drug Design
The molecular designing of drugs for specific purposes (such as DNA-binding, enzyme inhibition, anti-cancer efficacy, etc.) based on knowledge of molecular properties such as activity of functional groups, molecular geometry, and electronic structure, and also on information cataloged on analogous molecules. Drug design is generally computer-assisted molecular modeling and does not include pharmacokinetics, dosage analysis, or drug administration analysis.
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PubMed Articles
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