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

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.

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