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Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00226239
First Posted: September 26, 2005
Last Update Posted: July 11, 2017
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:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Pittsburgh
Results First Submitted: January 15, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cancer
Interventions: Drug: Docetaxel
Drug: Cisplatin
Drug: Cetuximab
Procedure: Radiation Therapy

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Head and Neck Cancer Patients Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.

Participant Flow for 3 periods

Period 1:   TPE, Induction Therapy
    Head and Neck Cancer Patients
STARTED   39 
COMPLETED   37 
NOT COMPLETED   2 

Period 2:   XPE, Definitive Therapy
    Head and Neck Cancer Patients
STARTED   37 
COMPLETED   33 
NOT COMPLETED   4 

Period 3:   Maintenance Cetuximab
    Head and Neck Cancer Patients
STARTED   31 
COMPLETED   17 
NOT COMPLETED   14 



  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
Head and Neck Cancer Patients Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.

Baseline Measures
   Head and Neck Cancer Patients 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Years]
Median (Full Range)
 55 
 (21 to 74) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  12.8% 
Male      34  87.2% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate (ORR)   [ Time Frame: Up to 36 months ]

2.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: Up to 36 months ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Up to 36 months ]

4.  Secondary:   2-year Overall Survival (OS)   [ Time Frame: Up to 24 months ]

5.  Secondary:   3-year Overall Survival (OS)   [ Time Frame: Up to 36 months ]

6.  Secondary:   Quality of Life (QOL)   [ Time Frame: Pre-treatment, Post-induction, 3 months after XPE and 12 months after XPE ]

7.  Other Pre-specified:   EGFR-related Serum Markers   [ Time Frame: Up to 36 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Rita Johnson, Associate Director of Clinical Research Services
Organization: UPMC Cancer Centers
phone: 412-647-8571
e-mail: johnsonr1@upmc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00226239     History of Changes
Other Study ID Numbers: 05-003
First Submitted: September 22, 2005
First Posted: September 26, 2005
Results First Submitted: January 15, 2016
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017