Arsenic Trioxide in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Trisenox (Arsenic Trioxide) in the Treatment of Unresectable Liver Cancer|
- Efficacy [ Designated as safety issue: No ]
- Safety and tolerability [ Designated as safety issue: Yes ]
|Study Start Date:||June 2004|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
- 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.
|United States, Pennsylvania|
|UPMC Cancer Centers|
|Pittsburgh, Pennsylvania, United States, 15232|
|Study Chair:||T. Clark Gamblin, MD||UPMC Cancer Center at UPMC Presbyterian|