Liver Cancer Clinical Trial
Official title:
Phase Ib Clinical Trial of Sorafenib in Combination With Transarterial Chemoembolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (HCC)
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, 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
the blood flow to the tumor. Giving sorafenib tosylate together with chemoembolization may
kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of sorafenib tosylate when given
together with chemoembolization with doxorubicin hydrochloride and mitomycin in treating
patients with liver cancer that cannot be removed by surgery.
OBJECTIVES:
Primary
- To determine the safety of sorafenib tosylate when given in combination with
transarterial chemoembolization (TACE) comprising doxorubicin hydrochloride and
mitomycin C in patients with unresectable hepatocellular carcinoma.
Secondary
- To estimate the time to progression (TTP) in patients treated with this regimen.
- To estimate the overall survival (OS) of patients treated with this regimen.
- To explore correlative relationships between measures of serum VEGF in the
peri-procedure TACE period and changes with TACE and sorafenib tosylate as well as
patient outcomes (TTP and OS).
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib tosylate twice daily on days 1-14. Patients then undergo
transarterial chemoembolization (TACE) comprising doxorubicin hydrochloride and mitomycin C
on days 17-19*. Patients then receive oral sorafenib tosylate twice daily beginning after
recovery from TACE and continuing in the absence of disease progression or unacceptable
toxicity.
NOTE: *A second course of TACE may be administered within 8 weeks after the first TACE
procedure.
Blood samples may be collected periodically for biomarker and pharmacokinetic analysis.
After completion of study treatment, patients are followed up at 3-4 weeks and then every 3
months for up to 3 years.
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