A Phase II Study of Oxaliplatin in Hepatocellular Cancer
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
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
Response rate evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)
Confidence intervals for the response rate will be established by calculating exact 95% confidence limits for a binomial parameter.
Up to 6 years
Beckman Research Institute
United States: Food and Drug Administration
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