Arsenic Trioxide in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT00128596|
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : April 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: arsenic trioxide||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Trisenox (Arsenic Trioxide) in the Treatment of Unresectable Liver Cancer|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||December 2005|
- Safety and tolerability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128596
|United States, Pennsylvania|
|UPMC Cancer Centers|
|Pittsburgh, Pennsylvania, United States, 15232|
|Study Chair:||T. Clark Gamblin, MD||UPMC Cancer Center at UPMC Presbyterian|