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

NCT00128596 | Completed Phase 2

• 3 other identifiers: PCI-04-06060CDR0000438662CTI-PCI-04-06060
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Efficacy

• Safety and tolerability

Interventions

arsenic trioxide DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• T. Clark Gamblin, MD

  UPMC Cancer Center at UPMC Presbyterian

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2005
• First Posted: August 10, 2005
• Study Start: June 1, 2004
• Primary Completion: December 1, 2005
• Last Updated: April 27, 2017

Record last verified: 2006-01

Locations

US (1)