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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00483405
First received: June 6, 2007
Last updated: June 13, 2017
Last verified: June 2017
Results First Received: March 28, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Liver Cancer
Interventions: Biological: cetuximab
Drug: capecitabine
Drug: oxaliplatin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 33 enrolled; 2 patients withdrew or refused prior to the beginning of protocol therapy, 2 patients were found to be ineligible, and 1 patient was withdrawn when diagnosis changed to sarcoma.

Reporting Groups
  Description
Single Arm Trial

Single Arm Trial

cetuximab: 250 mg/m2, intravenously, once per week

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.

oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle


Participant Flow:   Overall Study
    Single Arm Trial
STARTED   28 
COMPLETED   0 
NOT COMPLETED   28 
Adverse Event                8 
Lack of Efficacy                14 
Death                3 
Withdrawal by Subject                2 
Other complicating disease                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
29 patients received any protocol directed therapy, but only 28 patients were included in any efficacy analysis because one patient was found to have a sarcoma and was withdrawn from the study.

Reporting Groups
  Description
Single Arm Trial

Single Arm Trial

cetuximab: 250 mg/m2, intravenously, once per week

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.

oxaliplatin: 130 mg/m2, intravenously on Day 1 of each 21 day cycle


Baseline Measures
   Single Arm Trial 
Overall Participants Analyzed 
[Units: Participants]
 28 
Age 
[Units: Years]
Median (Full Range)
 
Participants Analyzed 
[Units: Participants]
 28 
   59 
 (46 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 28 
Female      5  17.9% 
Male      23  82.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 28 
Hispanic or Latino      1   3.6% 
Not Hispanic or Latino      27  96.4% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 28 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      9  32.1% 
White      17  60.7% 
More than one race      0   0.0% 
Unknown or Not Reported      2   7.1% 
The Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
Count of Participants
 
 
Participants Analyzed 
[Units: Participants]
 28 
 14 
 
Participants Analyzed 
[Units: Participants]
 28 
 12 
 
Participants Analyzed 
[Units: Participants]
 28 
 1 
[1]

A scale from 0-5 to describe a patient's level of functioning in terms of self care ability and activity level.

0. Fully active

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
  2. Ambulatory and capable of all self care but unable to carry out any work activities; up and about more than 50% of waking hours
  3. Capable of only limited self care; confined to bed or chair more than 50% of waking hours
  4. Completely disabled; cannot carry on any self care; totally confined to bed or chair
  5. Dead
Childs-Pugh Classification [1] [2] 
[Units: Participants]
Count of Participants
 
Class A (5-6 points)   
Participants Analyzed 
[Units: Participants]
 24 
Class A (5-6 points)   18 
Class B (7-9 points)   
Participants Analyzed 
[Units: Participants]
 24 
Class B (7-9 points)   6 
Class C (10-15 points)   
Participants Analyzed 
[Units: Participants]
 28 
Class C (10-15 points)   0 
[1] Child-Pugh scores five clinical features and is used to assess the prognosis of chronic liver disease and cirrhosis. The lower the points total, the better prognosis.
[2] Childs-Pugh was available only for the 24 evaluable patients.
Prior Therapy 
[Units: Participants]
Count of Participants
 
Yes   
Participants Analyzed 
[Units: Participants]
 28 
Yes   13 
None   
Participants Analyzed 
[Units: Participants]
 28 
None   15 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Disease Response Rate   [ Time Frame: 42 days (2 cycles) ]

2.  Secondary:   Number of Subjects Experiencing Adverse Events   [ Time Frame: every 3 weeks of treatment with an average of 15 weeks on treatment ]

3.  Secondary:   Overall Survival   [ Time Frame: Median 23 month follow-up ]

4.  Secondary:   Time to Progression   [ Time Frame: Median 23 month follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robin V. Johnson
Organization: UNC Lineberger Comprehensive Cancer Center
phone: 919-966-1125
e-mail: robin_v_johnson@med.unc.edu


Publications of Results:

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 )
Study First Received: June 6, 2007
Results First Received: March 28, 2017
Last Updated: June 13, 2017