NCT00052364

Oxaliplatin in Treating Patients With Liver Cancer

A Phase II Study of Oxaliplatin in Hepatocellular Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II trial to study the effectiveness of oxaliplatin in treating patients who have unresectable, recurrent or metastatic liver cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed description

PRIMARY OBJECTIVES: I. To assess response rate and progression free survival in patients with hepatocellular cancer treated with oxaliplatin. II. To assess the toxicity and tolerance of oxaliplatin in patient with hepatocellular cancer. III. To evaluate the mRNA expression of enzymes in tumors of the patients entered on this study which may be important to the cytotoxicity of oxaliplatin (ERCC1, mismatch repair, ribonucleotide reductase, bcl-2, bax, p53). An attempt will be made to obtain tumor biopsies from all patients. OUTLINE: This is a multicenter study. Patients are stratified according to presence of the fibrolamellar variant of hepatocellular cancer (yes vs no). Patients receive oxaliplatin IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study.

Conditions

• Adult Primary Hepatocellular Carcinoma
• Advanced Adult Primary Liver Cancer
• Localized Unresectable Adult Primary Liver Cancer
• Recurrent Adult Primary Liver Cancer

Interventions

Type	Name	Description
DRUG	oxaliplatin	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2002-09-01
• Primary completion: 2006-01-01
• First posted: 2003-01-27
• Last updated: 2013-06-18

Locations

1 site across 1 country: United States