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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Trisenox (Arsenic Trioxide) in the Treatment of Unresectable Liver Cancer

Conditions
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Liver Cancer

Intervention / Treatment
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* Drug: arsenic trioxide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: arsenic trioxide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 
| Safety and tolerability |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult primary hepatocellular carcinoma, advanced adult primary liver cancer, recurrent adult primary liver cancer