A Phase II Study of Oxaliplatin in Hepatocellular Cancer
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.
Interventional
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
No
Yun Yen
Principal Investigator
Beckman Research Institute
United States: Food and Drug Administration
NCI-2012-02830
NCT00052364
September 2002
Name | Location |
---|---|
City of Hope | Duarte, California 91010 |