Arsenic Trioxide in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery
- Conditions
- Liver Cancer
- Registration Number
- NCT00128596
- Lead Sponsor
- University of Pittsburgh
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability Efficacy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UPMC Cancer Centers
🇺🇸Pittsburgh, Pennsylvania, United States