Arsenic Trioxide in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery - Full Text View

Sponsored by:	UPMC Cancer Centers
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00128596

Purpose

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.

Condition	Intervention	Phase
Liver Cancer	Drug: arsenic trioxide	Phase II

MedlinePlus related topics: Arsenic Cancer Liver Cancer

Drug Information available for: Arsenic trioxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of Trisenox (Arsenic Trioxide) in the Treatment of Unresectable Liver Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Efficacy [ Designated as safety issue: No ]
Safety and tolerability [ Designated as safety issue: Yes ]

Estimated Enrollment:	25
Study Start Date:	June 2004

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128596

Locations

United States, Pennsylvania
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232

Sponsors and Collaborators

UPMC Cancer Centers

Investigators

Study Chair:

T. Clark Gamblin, MD

UPMC Cancer Center at UPMC Presbyterian

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000438662, PCI-04-06060, CTI-PCI-04-06060
Study First Received:	August 8, 2005
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00128596
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult primary hepatocellular carcinoma
advanced adult primary liver cancer
recurrent adult primary liver cancer

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms

Arsenic trioxide
Gastrointestinal Neoplasms
Recurrence
Hepatocellular carcinoma
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009