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Sorafenib Tosylate Before and After Hepatic Arterial Chemoembolization With Doxorubicin Hydrochloride and Mitomycin C in Treating Patients With Localized Liver Cancer That Cannot Be Removed by Surgery

Liver Cancer Clinical Trial

Official title:
Micro and Macro Arteriolar Blockade of Hepatocellular Carcinoma (HCC): Treatment With Sorafenib Before and After Hepatic Arterial Embolization (HAE) Therapy for Liver Cancer.

Clinical Trial Summary

RATIONALE: 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. Drugs used in chemotherapy, such as doxorubicin hydrochloride and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking blood flow to the tumor. Giving sorafenib tosylate before and after chemoembolization may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving sorafenib tosylate before and after hepatic arterial chemoembolization with doxorubicin hydrochloride and mitomycin C works in treating patients with localized liver cancer that cannot be removed by surgery.

Clinical Trial Description

OBJECTIVES:

Primary

- To evaluate the safety and tolerability of sorafenib tosylate therapy when administered before and after doxorubicin hydrochloride-based hepatic arterial chemoembolization (HACE) as assessed by NCI CTCAE v3.0 in patients with localized unresectable hepatocellular carcinoma.

Secondary

- To determine if sorafenib tosylate decreases the number of HACE treatments required to achieve radiologic tumor kill.

- To assess improvement in progression-free survival.

- To assess changes in monthly AFP levels in patients with AFP-producing tumors.

- To measure VEGF levels.

OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-14. Beginning ≥ 3 days later, patients undergo hepatic arterial chemoembolization (HACE)* with doxorubicin hydrochloride and mitomycin C. Beginning ≥ 3 days after the completion of HACE and/or once liver function returns to baseline, patients resume sorafenib tosylate twice daily for up to 6 months in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients may undergo more than one HACE treatment.

Blood samples are collected periodically for further laboratory analysis. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00949182
Study type Interventional
Source Rutgers, The State University of New Jersey
Contact
Status Completed
Phase Phase 2
Start date July 2009
Completion date June 2013
View Details
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