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

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: August 8, 2005
Last updated: August 18, 2009
Last verified: January 2006

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 Intervention Phase
Liver Cancer
Drug: arsenic trioxide
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Trisenox (Arsenic Trioxide) in the Treatment of Unresectable Liver Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Efficacy [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: June 2004
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00128596

United States, Pennsylvania
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Study Chair: T. Clark Gamblin, MD UPMC Cancer Center at UPMC Presbyterian
  More Information Identifier: NCT00128596     History of Changes
Other Study ID Numbers: CDR0000438662  PCI-04-06060  CTI-PCI-04-06060 
Study First Received: August 8, 2005
Last Updated: August 18, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
recurrent adult primary liver cancer

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Arsenic trioxide
Antineoplastic Agents processed this record on October 21, 2016