Clinical trial NCT00128596: Arsenic Trioxide in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery
Official title: A Phase II Study of Trisenox (Arsenic Trioxide) in the Treatment of Unresectable Liver Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Cancer
Keywords: adult primary hepatocellular carcinoma
advanced adult primary liver cancer
recurrent adult primary liver cancer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2005-08-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Efficacy
measure: Safety and tolerability
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Cancer Centers
state: Pennsylvania
Study officials:
affiliation: UPMC Cancer Center at UPMC Presbyterian
name: T. Clark Gamblin, MD
role: STUDY_CHAIR
References: