Liver Cancer Clinical Trial
Official title:
A Phase II Study of Trisenox (Arsenic Trioxide) in the Treatment of Unresectable Liver Cancer
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to
stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing.
PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating
patients with metastatic liver cancer that cannot be removed by surgery.
OBJECTIVES:
- Determine the efficacy of arsenic trioxide in patients with unresectable metastatic
hepatocellular carcinoma.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: Patients receive a loading dose of arsenic trioxide IV over 1-2 hours once daily on
days 1-5* in week 1 and then twice weekly in weeks 2-8. Courses repeat every 8 weeks in the
absence of disease progression or unacceptable toxicity.
NOTE: *The 5-day loading dose is only administered during course 1.
After completion of study treatment, patients are followed at 30 days and then periodically
for up to 2 years.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
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