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

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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Liver Cancer
Interventions Biological: cetuximab
Drug: capecitabine
Drug: oxaliplatin
Enrollment 33
Recruitment Details  
Pre-assignment Details 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or refused prior to the beginning of protocol therapy, 2 patients were found to be ineligible, and 1 patient was withdrawn when diagnosis changed to sarcoma.
Arm/Group Title Single Arm Trial
Hide Arm/Group Description

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

Period Title: Overall Study
Started 28
Completed 0
Not Completed 28
Reason Not Completed
Adverse Event             8
Lack of Efficacy             14
Death             3
Withdrawal by Subject             2
Other complicating disease             1
Arm/Group Title Single Arm Trial
Hide Arm/Group Description

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

Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
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but only 28 patients were included in any efficacy analysis because one patient was found to have a sarcoma and was withdrawn from the study.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 28 participants
59
(46 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
5
  17.9%
Male
23
  82.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Hispanic or Latino
1
   3.6%
Not Hispanic or Latino
27
  96.4%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
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] 
Measure Type: Count of Participants
Unit of measure:  Participants
0 Number Analyzed 28 participants
14
  50.0%
1 Number Analyzed 28 participants
12
  42.9%
2 Number Analyzed 28 participants
1
   3.6%
[1]
Measure Description:

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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Class A (5-6 points) Number Analyzed 24 participants
18
  75.0%
Class B (7-9 points) Number Analyzed 24 participants
6
  25.0%
Class C (10-15 points) Number Analyzed 28 participants
0
   0.0%
[1]
Measure Description: 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]
Measure Analysis Population Description: Childs-Pugh was available only for the 24 evaluable patients.
Prior Therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Yes Number Analyzed 28 participants
13
  46.4%
None Number Analyzed 28 participants
15
  53.6%
1.Primary Outcome
Title Disease Response Rate
Hide Description

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.

Time Frame 42 days (2 cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
Four patients received some protocol treatment but withdrew before completing one cycle without assessment of response.
Arm/Group Title Single Arm Trial
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants with response
12.5
(3 to 32)
2.Secondary Outcome
Title Number of Subjects Experiencing Adverse Events
Hide Description Adverse events will be assessed using CTCAE criteria.
Time Frame every 3 weeks of treatment with an average of 15 weeks on treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm Trial
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
29
 100.0%
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival will be calculated from time of enrollment to death or last contact date.
Time Frame Median 23 month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Four patients received some protocol treatment but withdrew before completing one cycle without assessment of response.
Arm/Group Title Single Arm Trial
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 24
Median (95% Confidence Interval)
Unit of Measure: months
4.4
(2.4 to 7.3)
4.Secondary Outcome
Title Time to Progression
Hide Description 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.
Time Frame Median 23 month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Four patients received some protocol treatment but withdrew before completing one cycle without assessment of response.
Arm/Group Title Single Arm Trial
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 24
Median (95% Confidence Interval)
Unit of Measure: months
4.5
(3.2 to 6.4)
Time Frame Toxicity was assessed the second week of cycle 1 then at the commencement of each subsequent cycle.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm Trial
Hide Arm/Group Description

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

All-Cause Mortality
Single Arm Trial
Affected / at Risk (%)
Total   27/29 (93.10%) 
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm Trial
Affected / at Risk (%)
Total   17/29 (58.62%) 
Blood and lymphatic system disorders   
Hemoglobin * 1  1/29 (3.45%) 
Cardiac disorders   
Conduction abnormality/atrioventricular heart block - AV Block-Third degree (Complete AV block) * 1  1/29 (3.45%) 
Gastrointestinal disorders   
Diarrhea * 1  5/29 (17.24%) 
Hemorrhage, GI - Esophagus * 1  1/29 (3.45%) 
Hemorrhage, GI - Rectum * 1  1/29 (3.45%) 
Hemorrhage, GI - Upper GI NOS * 1  1/29 (3.45%) 
Nausea * 1  1/29 (3.45%) 
Pain - Abdomen NOS * 1  2/29 (6.90%) 
Vomiting * 1  1/29 (3.45%) 
General disorders   
Edema: limb * 1  2/29 (6.90%) 
Edema: viscera * 1  1/29 (3.45%) 
Fatigue (asthenia, lethargy, malaise) * 1  3/29 (10.34%) 
Hepatobiliary disorders   
Liver dysfunction/failure (clinical) * 1  1/29 (3.45%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever) * 1  2/29 (6.90%) 
Infections and infestations   
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) * 1  4/29 (13.79%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Salivary gland * 1  1/29 (3.45%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS * 1  1/29 (3.45%) 
Investigations   
AST, SGOT(serum glutamic oxaloacetic transaminase) * 1  2/29 (6.90%) 
Bilirubin (hyperbilirubinemia) * 1  1/29 (3.45%) 
Creatinine * 1  1/29 (3.45%) 
Leukocytes (total WBC) * 1  1/29 (3.45%) 
Lipase * 1  1/29 (3.45%) 
Neutrophils/granulocytes (ANC/AGC) * 1  1/29 (3.45%) 
Metabolism and nutrition disorders   
Calcium, serum-low (hypocalcemia) * 1  1/29 (3.45%) 
Dehydration * 1  3/29 (10.34%) 
Magnesium, serum-low (hypomagnesemia) * 1  1/29 (3.45%) 
Phosphate, serum-low (hypophosphatemia) * 1  1/29 (3.45%) 
Potassium, serum-high (hyperkalemia) * 1  4/29 (13.79%) 
Sodium, serum-low (hyponatremia) * 1  2/29 (6.90%) 
Musculoskeletal and connective tissue disorders   
Pain - Back * 1  1/29 (3.45%) 
Nervous system disorders   
Encephalopathy * 1  5/29 (17.24%) 
Psychiatric disorders   
Confusion * 1  1/29 (3.45%) 
Renal and urinary disorders   
Renal failure * 1  3/29 (10.34%) 
Renal/Genitourinary - Other (Specify, __) * 1  1/29 (3.45%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath) * 1  2/29 (6.90%) 
Hypoxia * 1  1/29 (3.45%) 
Vascular disorders   
Hypotension * 1  2/29 (6.90%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Single Arm Trial
Affected / at Risk (%)
Total   27/29 (93.10%) 
Blood and lymphatic system disorders   
Hemoglobin * 1  15/29 (51.72%) 
Leukocytes (total WBC) * 1  14/29 (48.28%) 
Neutrophils/granulocytes (ANC/AGC) * 1  8/29 (27.59%) 
Platelets * 1  15/29 (51.72%) 
Gastrointestinal disorders   
Constipation * 1  7/29 (24.14%) 
Diarrhea * 1  16/29 (55.17%) 
Mucositis/stomatitis (functional/symptomatic) - Oral cavity * 1  15/29 (51.72%) 
Nausea * 1  18/29 (62.07%) 
Pain - Abdomen NOS * 1  9/29 (31.03%) 
Vomiting * 1  10/29 (34.48%) 
General disorders   
Fatigue (asthenia, lethargy, malaise) * 1  20/29 (68.97%) 
Investigations   
Albumin, serum-low (hypoalbuminemia) * 1  21/29 (72.41%) 
Alkaline phosphatase * 1  18/29 (62.07%) 
ALT, SGPT (serum glutamic pyruvic transaminase) * 1  15/29 (51.72%) 
AST, SGOT(serum glutamic oxaloacetic transaminase) * 1  18/29 (62.07%) 
Bilirubin (hyperbilirubinemia) * 1  14/29 (48.28%) 
Creatinine * 1  9/29 (31.03%) 
Metabolism and nutrition disorders   
Anorexia * 1  11/29 (37.93%) 
Calcium, serum-low (hypocalcemia) * 1  19/29 (65.52%) 
Glucose, serum-high (hyperglycemia) * 1  10/29 (34.48%) 
Magnesium, serum-low (hypomagnesemia) * 1  24/29 (82.76%) 
Potassium, serum-low (hypokalemia) * 1  10/29 (34.48%) 
Sodium, serum-low (hyponatremia) * 1  11/29 (37.93%) 
Nervous system disorders   
Neuropathy: sensory * 1  20/29 (68.97%) 
Respiratory, thoracic and mediastinal disorders   
Hiccoughs (hiccups, singultus) * 1  6/29 (20.69%) 
Skin and subcutaneous tissue disorders   
Rash: acne/acneiform * 1  16/29 (55.17%) 
Rash: hand-foot skin reaction * 1  6/29 (20.69%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robin V. Johnson
Organization: UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
EMail: robin_v_johnson@med.unc.edu
Layout table for additonal information
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