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Phase II Study of Oxaliplatin, Capecitabine, and Cetuximab in Advanced Hepatocellular Carcinoma

Phase 2
18 Years
Not Enrolling
Liver Cancer

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Trial Information

Phase II Study of Oxaliplatin, Capecitabine, and Cetuximab in Advanced Hepatocellular Carcinoma



- Determine the response rate in patients with advanced hepatocellular carcinoma and
hepatic dysfunction treated with oxaliplatin, capecitabine, and cetuximab.


- Determine the safety of this regimen in these patients.

- Determine the overall survival of patients treated with this regimen.

- Determine the time to tumor progression in patients treated with this regimen.

OUTLINE: This is an open label, nonrandomized study.

Patients receive oral capecitabine twice daily on days 1-14, cetuximab IV over 60-120
minutes on days 1, 8, and 15, and oxaliplatin IV over 120 minutes on day 1. Treatment
repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 3-4 weeks and then every 3
months thereafter.

Inclusion Criteria


- Meets 1 of the following criteria:

- Histologically confirmed hepatocellular carcinoma

- Alpha-fetoprotein (AFP) > 400 ng/mL with compatible mass by CT scan or MRI

- Metastatic disease OR not a candidate for surgical resection or immediate liver

- At least 1 site of measurable disease OR evaluable disease (AFP 2 times upper limit
of normal [ULN])

- No evidence of CNS metastases (unless CNS metastases stable for > 3 months)


- ECOG performance status 0-2

- ANC ≥ 1,500/mm³

- Hemoglobin ≥ 9 g/dL

- Platelet count ≥ 100,000/mm³

- Bilirubin ≤ 3 times ULN

- INR ≤ 1.5

- AST and ALT ≤ 5 times ULN

- Creatinine clearance > 50 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known hypersensitivity to capecitabine, cetuximab, or oxaliplatin or to other
murine products

- No comorbid condition which is deemed by the investigator to have a life expectancy
of < 6 months

- No New York Heart Association class III-IV coronary artery disease and/or heart

- No variceal bleeding within the past 60 days

- No other cancer within the past 5 years except cervical intraepithelial neoplasia,
nonmelanoma skin cancer, ductal carcinoma in situ, chronic lymphocytic leukemia, or
treated localized prostate cancer with a normal prostate specific antigen level

- No active drug or alcohol abuse

- No prior allergic reaction to a therapeutic antibody

- No serious, uncontrolled infection

- No history of uncontrolled seizures, CNS disorders, or psychiatric disability that,
in the opinion of the investigator, would preclude study participation or compliance

- No other serious uncontrolled medical condition that, in the opinion of the
investigator, would preclude study participation

- No lack of physical integrity of the upper gastrointestinal tract

- No malabsorption syndrome

- No known existing uncontrolled coagulopathy


- At least 4 weeks since prior participation in an investigational drug trial

- At least 4 weeks since prior major surgery and recovered

- At least 4 weeks since prior embolization, resection, or ablation

- No prior EGFR-targeting therapy

- No prior systemic chemotherapy or hepatic artery infusion of chemotherapy

- No concurrent phenytoin

- No concurrent therapeutic warfarin

- Low-dose non-therapeutic warfarin to maintain patency of venous access devices

Type of Study:


Study Design:

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

Outcome Measure:

Disease Response Rate

Outcome Description:

Radiographic response will be measured every sis weeks while subject is on treamtment. Response will be measured using RECIST criteria.

Outcome Time Frame:

every 6 weeks

Safety Issue:


Principal Investigator

Bert H. O'Neil, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Federal Government

Study ID:

LCCC 0421



Start Date:

October 2006

Completion Date:

December 2010

Related Keywords:

  • Liver Cancer
  • advanced adult primary liver cancer
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
  • adult primary hepatocellular carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570