Arsenic Trioxide in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery

Liver Cancer Clinical Trial

Official title:

A Phase II Study of Trisenox (Arsenic Trioxide) in the Treatment of Unresectable Liver Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128596
• Other study ID #: PCI-04-06060
• Secondary ID: CDR0000438662CTI
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2005
• Last updated: April 25, 2017
• Start date: June 2004

Study information

• Verified date: January 2006
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

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

• 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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• arsenic trioxide

Locations

Country	Name	City	State
United States	UPMC Cancer Centers	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy
Primary	Safety and tolerability