A Phase II Study of Trisenox (Arsenic Trioxide) in the Treatment of Unresectable Liver Cancer
18 Years
N/A
Both
Liver Cancer
Trial Information
A Phase II Study of Trisenox (Arsenic Trioxide) in the Treatment of Unresectable Liver Cancer
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy
Safety Issue:
No
Principal Investigator
T. Clark Gamblin, MD
Investigator Role:
Study Chair
Investigator Affiliation:
UPMC Cancer Center at UPMC Presbyterian
Authority:
United States: Federal Government
Study ID:
CDR0000438662
NCT ID:
NCT00128596
Start Date:
June 2004
Completion Date:
Related Keywords:
- Liver Cancer
- adult primary hepatocellular carcinoma
- advanced adult primary liver cancer
- recurrent adult primary liver cancer
- Liver Neoplasms
Name | Location |
|---|---|
| UPMC Cancer Centers | Pittsburgh, Pennsylvania 15232 |
