Advanced Adult Primary Liver Cancer Clinical Trial
Official title:
A Phase II Study of Oxaliplatin in Hepatocellular Cancer
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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