Liver Cancer
Conditions
Keywords
adult primary hepatocellular carcinoma, advanced adult primary liver cancer, recurrent adult primary liver cancer
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.
Detailed description
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.
Interventions
DRUGarsenic trioxide
Sponsors
University of Pittsburgh
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy | — |
| Safety and tolerability | — |
Countries
United States
Outcome results
None listed