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


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

This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) August 2005

Sponsors and Collaborators: University of Pittsburgh Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00128596

Purpose

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
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
recurrent adult primary liver cancer
 Drug: arsenic trioxide
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Liver Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Arsenic Trioxide in Patients With Unresectable Metastatic Hepatocellular Carcinoma

Further Study Details: 

OBJECTIVES:

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
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

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00128596


Pennsylvania
      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15232,  United States; Recruiting
Brian I. Carr, MD  412-692-2007 

Study chairs or principal investigators

Brian I. Carr, MD,  Study Chair,  University of Pittsburgh Cancer Institute   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000438662; PCI-04-06060; CTI-PCI-04-06060
Last Updated:  August 9, 2005
Record first received:  August 8, 2005
ClinicalTrials.gov Identifier:  NCT00128596
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23


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