Status:
COMPLETED
Arsenic Trioxide in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery
Lead Sponsor:
University of Pittsburgh
Conditions:
Liver Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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...
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. OU...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00128596
Start Date
June 1 2004
Last Update
April 27 2017
Active Locations (1)
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1
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232