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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128596
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : April 27, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Liver Cancer Drug: arsenic trioxide Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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

Primary Outcome Measures :
  1. Efficacy
  2. Safety and tolerability

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed hepatocellular carcinoma

    • Unresectable metastatic disease
  • Ascites allowed provided it is minimal



  • Over 18

Performance status

  • 0-2

Life expectancy

  • Not specified


  • WBC > 2,500/mm^3
  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 75,000/mm^3


  • Bilirubin < 2.5 mg/dL
  • AST < 2.5 times upper limit of normal


  • Not specified


  • QTc interval ≤ 460 msec AND potassium and magnesium normal


  • 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


Biologic therapy

  • No concurrent biologic therapy


  • More than 4 weeks since prior and no other concurrent chemotherapy

Endocrine therapy

  • Not specified


  • More than 4 weeks since prior and no concurrent radiotherapy


  • Not specified


  • No other concurrent investigational agents

Information from the National Library of Medicine

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 identifier (NCT number): NCT00128596

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United States, Pennsylvania
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
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Study Chair: T. Clark Gamblin, MD UPMC Cancer Center at UPMC Presbyterian
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Responsible Party: University of Pittsburgh Identifier: NCT00128596    
Other Study ID Numbers: PCI-04-06060
CDR0000438662 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: January 2006
Keywords provided by University of Pittsburgh:
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
recurrent adult primary liver cancer
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Arsenic Trioxide
Antineoplastic Agents