Arsenic Trioxide in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Cancer
Intervention: arsenic trioxide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s): T. Clark Gamblin, MD, Study Chair, Affiliation: UPMC Cancer Center at UPMC Presbyterian
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.
Clinical Details
Official title: A Phase II Study of Trisenox (Arsenic Trioxide) in the Treatment of Unresectable Liver Cancer
Study design: Masking: Open Label, Primary Purpose: Treatment
Primary outcome: EfficacySafety and tolerability
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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
- 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
Locations and Contacts
UPMC Cancer Centers, Pittsburgh, Pennsylvania 15232, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 2004
Last updated: August 18, 2009
|