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Oxaliplatin, Capecitabine, and Cetuximab in Treating Patients With Advanced Liver Cancer (NRR)

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center Identifier:
First received: June 6, 2007
Last updated: January 20, 2016
Last verified: January 2016

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy together with a monoclonal antibody may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with cetuximab works in treating patients with advanced liver cancer.

Condition Intervention Phase
Liver Cancer
Biological: cetuximab
Drug: capecitabine
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Oxaliplatin, Capecitabine, and Cetuximab in Advanced Hepatocellular Carcinoma

Resource links provided by NLM:

Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Disease Response Rate [ Time Frame: every 6 weeks ]
    Radiographic response will be measured every sis weeks while subject is on treamtment. Response will be measured using RECIST criteria.

Secondary Outcome Measures:
  • Number of subjects experiencing adverse events [ Time Frame: every 3 weeks of treatment ]
    Adverse events will be assessed using CTCAE critera.

  • Overall Survival [ Time Frame: time of enrollment until death ]
    Overall survival will be calculated from time of enrollment to death or last contact date.

  • Time to progression [ Time Frame: Enrollment until confirmed disease progression ]
    Time to progression will be calculated from the time of enrollment until confirmed disease progression

Enrollment: 33
Study Start Date: October 2006
Study Completion Date: December 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm Trial
Single Arm Trial
Biological: cetuximab
250 mg/m2, intravenously, once per week
Other Name: Erbitux
Drug: capecitabine
850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
Other Name: Xeloda
Drug: oxaliplatin
130 mg/m2, intravenously on Day 1 of each 21 day cycle
Other Name: Eloxatin

Detailed Description:



  • 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.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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 transplantation
  • 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 failure
  • 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 allowed
  Contacts and Locations
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Please refer to this study by its identifier: NCT00483405

United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Bert H. O'Neil, MD UNC Lineberger Comprehensive Cancer Center
Principal Investigator: Michael A. Morse, MD Duke University
  More Information

Responsible Party: UNC Lineberger Comprehensive Cancer Center Identifier: NCT00483405     History of Changes
Other Study ID Numbers: LCCC 0421
CDR0000550159 ( Other Identifier: PDQ number )
Study First Received: June 6, 2007
Last Updated: January 20, 2016

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
advanced adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on April 21, 2017