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

NCT ID: NCT00128596

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30

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 phase II trial is studying how well arsenic trioxide works in treating patients with metastatic liver cancer that cannot be removed by surgery.

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.

Conditions

Liver Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

arsenic trioxide

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

T. Clark Gamblin, MD

Role: STUDY_CHAIR

UPMC Cancer Center at UPMC Presbyterian

Locations

UPMC Cancer Centers

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

CDR0000438662

Identifier Type: REGISTRY

Identifier Source: secondary_id

CTI-PCI-04-06060

Identifier Type: -

Identifier Source: secondary_id

PCI-04-06060

Identifier Type: -

Identifier Source: org_study_id