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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00466505
First Posted: April 27, 2007
Last Update Posted: December 19, 2012
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jordan Berlin, MD, Vanderbilt-Ingram Cancer Center
Results First Submitted: August 15, 2011  
Study Type: Interventional
Study Design: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study recruitment period was May 2005 through January 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 18 people signed consent to participate in this study. One was determined ineligible, for a total of 17 patients on study.

Reporting Groups
  Description
Therapeutic Intervention No text entered.

Participant Flow:   Overall Study
    Therapeutic Intervention
STARTED   17 
COMPLETED   0 
NOT COMPLETED   17 
disease progression                13 
Adverse Event                4 



  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.
No text entered.

Reporting Groups
  Description
Therapeutic Intervention No text entered.

Baseline Measures
   Therapeutic Intervention 
Overall Participants Analyzed 
[Units: Participants]
 17 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   12 
>=65 years   5 
Age 
[Units: Years]
Mean (Standard Deviation)
 60  (1) 
Gender 
[Units: Participants]
 
Female   7 
Male   10 
Region of Enrollment 
[Units: Participants]
 
United States   17 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: On study date to off study date in this study with median 9.76 months ]

2.  Secondary:   Patient Response to Treatment   [ Time Frame: On study date to off study date in this study with median 9.76 months ]

3.  Secondary:   Overall Survival   [ Time Frame: On study date to off study date in this study with median 9.76 months ]

4.  Secondary:   One Year Survival Rate   [ Time Frame: 1 year from on-study date ]

5.  Secondary:   Number of Patients With Each Worst-grade Toxicity Response   [ Time Frame: On study date to off study date in this study with median 9.76 months ]

6.  Secondary:   Urinary PGE-M : Treatment Cycle 1   [ Time Frame: on-study week 5 ]

7.  Secondary:   Serum TGF-alpha: Treatment Cycle 1   [ Time Frame: on-study week 5 ]

8.  Secondary:   Urinary PGE-M : Treatment Cycle 2   [ Time Frame: on-study week 9 ]

9.  Secondary:   Serum TGF-alpha: Treatment Cycle 2   [ Time Frame: on-study week 9 ]


  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: Jordan Berlin, MD
Organization: Vanderbilt-Ingram Cancer center
phone: 615-343-4128
e-mail: jordan.berlin@vanderbilt.edu



Responsible Party: Jordan Berlin, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00466505     History of Changes
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