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


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy

Safety Issue:

No

Principal Investigator

T. Clark Gamblin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UPMC Cancer Center at UPMC Presbyterian

Authority:

United States: Federal Government

Study ID:

CDR0000438662

NCT ID:

NCT00128596

Start Date:

June 2004

Completion Date:

Related Keywords:

  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • Liver Neoplasms

Name

Location

UPMC Cancer CentersPittsburgh, Pennsylvania  15232