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Cetuximab & Celecoxib for Metastatic Colorectal Cancer or Colorectal Cancer That Cannot Be Removed by Surgery

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: NCT00466505
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : November 16, 2011
Last Update Posted : December 19, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jordan Berlin, MD, Vanderbilt-Ingram Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Biological: cetuximab
Drug: celecoxib
Genetic: proteomic profiling
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: mass spectrometry
Enrollment 17
Recruitment Details Study recruitment period was May 2005 through January 2007.
Pre-assignment Details A total of 18 people signed consent to participate in this study. One was determined ineligible, for a total of 17 patients on study.
Arm/Group Title Therapeutic Intervention
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 17
Completed 0
Not Completed 17
Reason Not Completed
disease progression             13
Adverse Event             4
Arm/Group Title Therapeutic Intervention
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
  70.6%
>=65 years
5
  29.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
60  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
7
  41.2%
Male
10
  58.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description Number of days from study enrollment to evidence of progressive disease radiographically, with progression defined under RECIST criteria as at least 20% increase in sum of longest diameter of target lesions
Time Frame On study date to off study date in this study with median 9.76 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapeutic Intervention
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[Not Specified]
Overall Number of Participants Analyzed 17
Median (Full Range)
Unit of Measure: Days
55
(10 to 295)
2.Secondary Outcome
Title Patient Response to Treatment
Hide Description Number of patients in each response category according to RECIST criteria: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Time Frame On study date to off study date in this study with median 9.76 months
Hide Outcome Measure Data
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[Not Specified]
Arm/Group Title Therapeutic Intervention
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[Not Specified]
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
Partial Response 2
Progressive Disease 7
Stable Disease 4
Unknown 4
3.Secondary Outcome
Title Overall Survival
Hide Description Median survival time in months, from on-study date to date of death
Time Frame On study date to off study date in this study with median 9.76 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapeutic Intervention
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[Not Specified]
Overall Number of Participants Analyzed 17
Median (Inter-Quartile Range)
Unit of Measure: Months
8.54
(5.58 to 10.74)
4.Secondary Outcome
Title One Year Survival Rate
Hide Description Percent of patients who remain alive one year from on-study date
Time Frame 1 year from on-study date
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapeutic Intervention
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[Not Specified]
Overall Number of Participants Analyzed 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
17.6
(6.32 to 49.3)
5.Secondary Outcome
Title Number of Patients With Each Worst-grade Toxicity Response
Hide Description Number of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death.
Time Frame On study date to off study date in this study with median 9.76 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapeutic Intervention
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[Not Specified]
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: patients
No. of patients with worst-grade toxicity of 1 0
No. of patients with worst-grade toxicity of 2 0
No. of patients with worst-grade toxicity of 3 1
No. of patients with worst-grade toxicity of 4 1
No. of patients with worst-grade toxicity of 5 0
6.Secondary Outcome
Title Urinary PGE-M : Treatment Cycle 1
Hide Description Measurement in ng/mL of a stable metabolite of prostaglandin E2 (PGE-M) in urine during treatment cycle 1
Time Frame on-study week 5
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[Not Specified]
Arm/Group Title Therapeutic Intervention
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[Not Specified]
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
Stable or PR (n=6) 30.42  (17.15)
Progressive Disease (n=11) 21.94  (17.13)
7.Secondary Outcome
Title Serum TGF-alpha: Treatment Cycle 1
Hide Description Measurement in ng/mL of tumor growth factor-alpha (TGF-alpha) in serum samples during treatment cycle 1
Time Frame on-study week 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapeutic Intervention
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[Not Specified]
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
Stable or PR (n=5) 26.38  (17.15)
Progressive Disease (n=10) 25.90  (10.93)
8.Secondary Outcome
Title Urinary PGE-M : Treatment Cycle 2
Hide Description Measurement in ng/mL of a stable metabolite of prostaglandin E2 (PGE-M) in urine during treatment cycle 2
Time Frame on-study week 9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapeutic Intervention
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[Not Specified]
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
Stable or PR (n=6) 28.42  (25.73)
Progressive Disease (n=4) 29.76  (41.34)
9.Secondary Outcome
Title Serum TGF-alpha: Treatment Cycle 2
Hide Description Measurement in ng/mL of tumor growth factor-alpha (TGF-alpha) in serum samples during treatment cycle 2
Time Frame on-study week 9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapeutic Intervention
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[Not Specified]
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
Stable or PR (n=6) 48.02  (16.94)
Progressive Disease (n=4) 49.95  (27.27)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Therapeutic Intervention
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Therapeutic Intervention
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Therapeutic Intervention
Affected / at Risk (%) # Events
Total   2/17 (11.76%)    
Nervous system disorders   
neurology, brain mets  1/17 (5.88%)  1
Renal and urinary disorders   
Hemorrhage, bladder  1/17 (5.88%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Therapeutic Intervention
Affected / at Risk (%) # Events
Total   17/17 (100.00%)    
Blood and lymphatic system disorders   
AST, SGOT  3/17 (17.65%)  3
leukocytes  1/17 (5.88%)  1
Eye disorders   
cataract  1/17 (5.88%)  1
eye irritation  2/17 (11.76%)  3
blurred vision  2/17 (11.76%)  2
Gastrointestinal disorders   
constipation  4/17 (23.53%)  4
diarrhea  7/17 (41.18%)  8
dyspepsi  3/17 (17.65%)  3
hemorrhage, rectum  3/17 (17.65%)  3
hemorrhoids  1/17 (5.88%)  1
anal incontinence  1/17 (5.88%)  1
reflux  2/17 (11.76%)  2
pain, abdominal  8/17 (47.06%)  8
pain, rectum  2/17 (11.76%)  2
vomiting  1/17 (5.88%)  1
flatulence  1/17 (5.88%)  1
General disorders   
allergic reaction  3/17 (17.65%)  3
edema  2/17 (11.76%)  3
fatigue  12/17 (70.59%)  13
fever  2/17 (11.76%)  2
Infections and infestations   
infection  3/17 (17.65%)  3
infection with normal ANC  1/17 (5.88%)  1
Investigations   
alkaline phosphatase  4/17 (23.53%)  5
hemoglobin  7/17 (41.18%)  11
platelets  2/17 (11.76%)  2
Metabolism and nutrition disorders   
hypoalbuminemia  2/17 (11.76%)  2
ALT, SGPT  2/17 (11.76%)  2
hyperbilirubinemia  3/17 (17.65%)  3
hypocalcemia  3/17 (17.65%)  4
hypomagnesiumia  6/17 (35.29%)  6
hypercholesterolemia  1/17 (5.88%)  1
hyperglycemia  4/17 (23.53%)  5
hypokalemia  5/17 (29.41%)  5
hyponatremia  1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders   
muscle weakness  2/17 (11.76%)  2
pain, back  3/17 (17.65%)  3
pain, extremity  1/17 (5.88%)  1
pain, muscle  1/17 (5.88%)  1
pain, rib cage  2/17 (11.76%)  2
Nervous system disorders   
dizziness  2/17 (11.76%)  2
restless leg  2/17 (11.76%)  2
peripheral neuropathy  5/17 (29.41%)  5
pain, head  1/17 (5.88%)  1
tremor  1/17 (5.88%)  1
Psychiatric disorders   
anorexia  4/17 (23.53%)  4
insomnia  4/17 (23.53%)  4
agitation  2/17 (11.76%)  2
depression  2/17 (11.76%)  2
Renal and urinary disorders   
hemorrhage, bladder  4/17 (23.53%)  4
urinary frequency  2/17 (11.76%)  2
urinary retention  2/17 (11.76%)  2
Reproductive system and breast disorders   
vaginal discharge  1/17 (5.88%)  1
Respiratory, thoracic and mediastinal disorders   
cough  4/17 (23.53%)  4
dyspnea  3/17 (17.65%)  4
hemorrhage, pulmonary  1/17 (5.88%)  1
hiccoughs  1/17 (5.88%)  1
hoarseness  1/17 (5.88%)  1
Skin and subcutaneous tissue disorders   
dermatologic general  7/17 (41.18%)  8
nail changes  2/17 (11.76%)  3
balanitis  2/17 (11.76%)  2
pruritus, itching  5/17 (29.41%)  5
rash, desquamation  15/17 (88.24%)  20
hand, foot rash  1/17 (5.88%)  1
Vascular disorders   
hot flashes  1/17 (5.88%)  1
hypotension  1/17 (5.88%)  1
diaphoresis, sweating  2/17 (11.76%)  2
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: Jordan Berlin, MD
Organization: Vanderbilt-Ingram Cancer center
Phone: 615-343-4128
EMail: jordan.berlin@vanderbilt.edu
Layout table for additonal information
Responsible Party: Jordan Berlin, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00466505    
Other Study ID Numbers: VICC GI 0410
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-GI-0410
VU-IRB-040227
First Submitted: April 25, 2007
First Posted: April 27, 2007
Results First Submitted: August 15, 2011
Results First Posted: November 16, 2011
Last Update Posted: December 19, 2012