Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00483405
Recruitment Status : Completed
First Posted : June 7, 2007
Results First Posted : May 9, 2017
Last Update Posted : July 12, 2017
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE June 6, 2007
First Posted Date  ICMJE June 7, 2007
Results First Submitted Date  ICMJE March 28, 2017
Results First Posted Date  ICMJE May 9, 2017
Last Update Posted Date July 12, 2017
Study Start Date  ICMJE October 2006
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2007)
Response every 6 weeks during treatment
Change History Complete list of historical versions of study NCT00483405 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2007)
  • Safety every 3 weeks during treatment
  • Survival
  • Time to Progression
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxaliplatin, Capecitabine, and Cetuximab in Treating Patients With Advanced Liver Cancer
Official Title  ICMJE Phase II Study of Oxaliplatin, Capecitabine, and Cetuximab in Advanced Hepatocellular Carcinoma
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Single Arm Trial
Single Arm Trial
Interventions:
  • Biological: cetuximab
  • Drug: capecitabine
  • Drug: oxaliplatin
Publications * Sanoff HK, Bernard S, Goldberg RM, Morse MA, Garcia R, Woods L, Moore DT, O'Neil BH. Phase II Study of Capecitabine, Oxaliplatin, and Cetuximab for Advanced Hepatocellular Carcinoma. Gastrointest Cancer Res. 2011 May;4(3):78-83.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2012)
33
Original Enrollment  ICMJE
 (submitted: June 6, 2007)
25
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00483405
Other Study ID Numbers  ICMJE LCCC 0421
KL2RR025746 ( U.S. NIH Grant/Contract )
5K23CA118431-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party UNC Lineberger Comprehensive Cancer Center
Study Sponsor  ICMJE UNC Lineberger Comprehensive Cancer Center
Collaborators  ICMJE
  • Sanofi
  • Roche Pharma AG
  • Bristol-Myers Squibb
  • National Center for Research Resources (NCRR)
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Bert H. O'Neil, MD UNC Lineberger Comprehensive Cancer Center
Principal Investigator: Michael A. Morse, MD Duke University
PRS Account UNC Lineberger Comprehensive Cancer Center
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP