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Clinical Trial: Arsenic Trioxide in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery
This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) August 2005
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| adult primary hepatocellular carcinoma advanced adult primary liver cancer recurrent adult primary liver cancer | Drug: arsenic trioxide Procedure: chemotherapy | Phase II |
MedlinePlus related topics: Liver Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Arsenic Trioxide in Patients With Unresectable Metastatic Hepatocellular Carcinoma
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
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
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
Location and Contact Information
Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, 15232, United States; Recruiting
Brian I. Carr, MD, Study Chair, University of Pittsburgh Cancer Institute
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
Last Updated: August 9, 2005
Record first received: August 8, 2005
ClinicalTrials.gov Identifier: NCT00128596
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23

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