NCT01042041

Sorafenib Tosylate and Chemoembolization in Treating Patients With Unresectable Liver Cancer

A Phase 1 Study of Sorafenib Integrated With Chemoembolization for Patients With Unresectable Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Sorafenib tosylate 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. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. PURPOSE: This phase I trial is studying side effects and best dose of sorafenib tosylate when given together with chemoembolization in treating patients with unresectable liver cancer.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the toxicity and safety of integrating sorafenib with chemoembolization for unresectable hepatocellular carcinoma. SECONDARY OBJECTIVE: I. To observe the imaging response (AASLD/EASL modification of RECIST) and time to progression following chemoembolization in conjunction with sorafenib. OUTLINE: Patients receive oral sorafenib tosylate twice daily. Beginning 2 weeks later, patients undergo chemoembolization with cisplatin, doxorubicin hydrochloride, and mitomycin C. Chemoembolizaton repeats once a month for up to 4 procedures in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 4 weeks and then every 3 months.

Conditions

• Hepatocellular Carcinoma
• Liver Cancer
• Localized Unresectable Liver Cancer

Interventions

Type	Name	Description
DRUG	sorafenib tosylate	Given orally
DRUG	doxorubicin hydrochloride	Given via transarterial/hepatic chemoembolization
DRUG	cisplatin	Given via transarterial/hepatic chemoembolization
DRUG	mitomycin C	Given via transarterial/hepatic chemoembolization
PROCEDURE	transarterial chemoembolization
PROCEDURE	hepatic artery embolization

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-01-05
• Last updated: 2013-02-26

Locations

1 site across 1 country: United States