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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Given IV
Correlative studies
City of Hope
Duarte, California, United States
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.
Time frame: Up to 6 years
Time to progression
Time frame: Up to 6 years
Duration of overall survival
Estimated using the product-limit method of Kaplan and Meier.
Time frame: Up to 6 years
Progression-free survival
Estimated using the product-limit method of Kaplan and Meier.
Time frame: Up to 6 years
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