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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00483405
First Posted: June 7, 2007
Last Update Posted: July 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Sanofi
Roche Pharma AG
Bristol-Myers Squibb
National Center for Research Resources (NCRR)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
  Purpose

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: None (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: 42 days (2 cycles) ]

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

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.



Secondary Outcome Measures:
  • Number of Subjects Experiencing Adverse Events [ Time Frame: every 3 weeks of treatment with an average of 15 weeks on treatment ]
    Adverse events will be assessed using CTCAE criteria.

  • Overall Survival [ Time Frame: Median 23 month follow-up ]
    Overall survival will be calculated from time of enrollment to death or last contact date.

  • Time to Progression [ Time Frame: Median 23 month follow-up ]
    Time to progression will be calculated from the time of enrollment until confirmed disease progression. Defined by RECIST (Response Evaluation Criteria in Solid Tumors), Progressive Disease (PD) - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.


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:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

DISEASE CHARACTERISTICS:

  • 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 central nervous system (CNS) metastases (unless CNS metastases stable for > 3 months)

PATIENT CHARACTERISTICS:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1,500/mm³
  • Hemoglobin ≥ 9 g/dL
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 3 times ULN
  • International normalized ratio (INR) ≤ 1.5
  • Aspartate aminotransferase (AST) and alanine aminotransferase (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

PRIOR CONCURRENT THERAPY:

  • 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 epidermal growth factor receptor (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483405


Locations
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
Sanofi
Roche Pharma AG
Bristol-Myers Squibb
National Center for Research Resources (NCRR)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Bert H. O'Neil, MD UNC Lineberger Comprehensive Cancer Center
Principal Investigator: Michael A. Morse, MD Duke University
  More Information

Additional Information:
Publications:
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00483405     History of Changes
Other Study ID Numbers: LCCC 0421
KL2RR025746 ( U.S. NIH Grant/Contract )
5K23CA118431-02 ( U.S. NIH Grant/Contract )
First Submitted: June 6, 2007
First Posted: June 7, 2007
Results First Submitted: March 28, 2017
Results First Posted: May 9, 2017
Last Update Posted: July 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Capecitabine
Oxaliplatin
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents