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Arsenic Trioxide in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
arsenic trioxide
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, advanced adult primary liver cancer, recurrent adult primary liver cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed hepatocellular carcinoma Unresectable metastatic disease Ascites allowed provided it is minimal PATIENT CHARACTERISTICS: Age Over 18 Performance status 0-2 Life expectancy Not specified Hematopoietic WBC > 2,500/mm^3 Absolute neutrophil count > 1,500/mm^3 Platelet count > 75,000/mm^3 Hepatic Bilirubin < 2.5 mg/dL AST < 2.5 times upper limit of normal Renal Not specified Cardiovascular QTc interval ≤ 460 msec AND potassium and magnesium normal Other Not pregnant or nursing Negative pregnancy test Fertile female patients must use effective double-method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment (during and for ≥ 4 weeks after completion of study treatment for male patients) No blood, ova, or sperm donation during study treatment Potassium > 4.0 mEq/dL Magnesium > 1.8 mg/dL PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent biologic therapy Chemotherapy More than 4 weeks since prior and no other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy More than 4 weeks since prior and no concurrent radiotherapy Surgery Not specified Other No other concurrent investigational agents

Sites / Locations

  • UPMC Cancer Centers

Outcomes

Primary Outcome Measures

Efficacy
Safety and tolerability

Secondary Outcome Measures

Full Information

First Posted
August 8, 2005
Last Updated
April 25, 2017
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00128596
Brief Title
Arsenic Trioxide in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery
Official Title
A Phase II Study of Trisenox (Arsenic Trioxide) in the Treatment of Unresectable Liver Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
adult primary hepatocellular carcinoma, advanced adult primary liver cancer, recurrent adult primary liver cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
arsenic trioxide
Primary Outcome Measure Information:
Title
Efficacy
Title
Safety and tolerability

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed hepatocellular carcinoma Unresectable metastatic disease Ascites allowed provided it is minimal PATIENT CHARACTERISTICS: Age Over 18 Performance status 0-2 Life expectancy Not specified Hematopoietic WBC > 2,500/mm^3 Absolute neutrophil count > 1,500/mm^3 Platelet count > 75,000/mm^3 Hepatic Bilirubin < 2.5 mg/dL AST < 2.5 times upper limit of normal Renal Not specified Cardiovascular QTc interval ≤ 460 msec AND potassium and magnesium normal Other Not pregnant or nursing Negative pregnancy test Fertile female patients must use effective double-method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment (during and for ≥ 4 weeks after completion of study treatment for male patients) No blood, ova, or sperm donation during study treatment Potassium > 4.0 mEq/dL Magnesium > 1.8 mg/dL PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent biologic therapy Chemotherapy More than 4 weeks since prior and no other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy More than 4 weeks since prior and no concurrent radiotherapy Surgery Not specified Other No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T. Clark Gamblin, MD
Organizational Affiliation
UPMC Cancer Center at UPMC Presbyterian
Official's Role
Study Chair
Facility Information:
Facility Name
UPMC Cancer Centers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Arsenic Trioxide in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery

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