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A Phase II Study of Oxaliplatin in Hepatocellular Cancer

Phase 2
18 Years
Not Enrolling
Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer

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Trial Information

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.

Inclusion Criteria:

- Patients must have histologically confirmed HCC which is recurrent, metastatic or

- Patients may have up to two prior chemotherapy regimes; in addition, they may have
had previous radiation, chemoembolization, and/or alcohol injections

- Patients must have measurable disease, defined as lesions that can be accurately
measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with
conventional techniques or as >= 10 mm with spiral CT scan, and which has clearly
progressed during the observation interval prior to participation in this study;
pleural effusions and ascites will not be considered measurable, but may be present
in addition to the measurable lesion(s)

- Karnofsky performance status >= 70%; patients should have an expected survival of at
least 2 months

- Leukocytes >= 3,000/μl

- Absolute neutrophil count >= 1,500/μl

- Platelets >= 100,000/μl

- Total bilirubin < 3.0 g/dl

- AST(SGOT)/ALT(SGPT) =< 5 X institutional upper limit of normal

- Creatinine < 2.0 OR measured creatinine clearance >= 60 mL/min for patients with
creatinine levels above institutional normal

- Brain metastasis is not an exclusion, however, patients are only eligible if they
have had successful control of the brain tumor(s) by surgery or stereotactic RT

- Patients with no evidence of clinically significant neuropathy

- All prior therapy must have been completed at least 4 weeks prior to the patient's
entry on this trial

- The effects of oxaliplatin on the developing human fetus at the recommended
therapeutic dose are unknown; for this reason and because DNA alkylating agents are
known to be teratogenic, women of child-bearing potential and men must agree to use
adequate contraception (hormonal or barrier method of birth control) prior to study
entry and for the duration of study participation; should a woman become pregnant or
suspect she is pregnant while participating in this study, she should inform her
treating physician immediately

- Because the risk of toxicity in nursing infants secondary to oxaliplatin treatment of
the mother is unknown but may be harmful, breastfeeding should be discontinued if the
mother is treated with oxaliplatin

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patient has prior oxaliplatin treatment or undergoing therapy with other
investigational agents

- History of allergy to platinum compounds or to antiemetics appropriate for
administration in conjunction with protocol-directed chemotherapy

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, or unstable angina pectoris, or
cardiac arrhythmia

- HIV-positive patients receiving anti-retroviral therapy (HAART) are excluded from the
study because of possible pharmacokinetic interactions

- Patients with a diagnosis of pulmonary fibrosis or a pulmonary interstitial process

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Description:

Confidence intervals for the response rate will be established by calculating exact 95% confidence limits for a binomial parameter.

Outcome Time Frame:

Up to 6 years

Safety Issue:


Principal Investigator

Yun Yen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

September 2002

Completion Date:

Related Keywords:

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



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