Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128596
Status:
COMPLETED
Last Update Posted:
2017-04-27
First Post:
2005-08-08
Brief Title:
Arsenic Trioxide in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Phase II Study of Trisenox Arsenic Trioxide in the Treatment of Unresectable Liver Cancer
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTI-PCI-04-06060 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000438662 | REGISTRY | None | None |