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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:
Collaborator:
Information provided by (Responsible Party):
Jordan Berlin, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00466505
First received: April 25, 2007
Last updated: December 14, 2012
Last verified: December 2012
Results First Received: August 15, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[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
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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


No publications provided


Responsible Party: Jordan Berlin, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00466505     History of Changes
Other Study ID Numbers: VICC GI 0410, P30CA068485, VU-VICC-GI-0410, VU-IRB-040227
Study First Received: April 25, 2007
Results First Received: August 15, 2011
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration