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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Treatments: Arsenic Trioxide

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