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Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01412229
First received: August 5, 2011
Last updated: July 5, 2017
Last verified: July 2017
Results First Received: March 29, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Interventions: Drug: Cetuximab
Drug: Nab-paclitaxel
Drug: Carboplatin

  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
Subjects were recruited from 10/12/2011 through 4/24/2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Sixty-seven subjects were consented to this trial. Of these, 29 were not eligible. 38 subjects were treated.

Reporting Groups
  Description
Treatment
  • nab-paclitaxel 100mg/m2
  • Carboplatin Area under the Curve (AUC2) (IV)
  • Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks

Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.

Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.

Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.


Participant Flow:   Overall Study
    Treatment
STARTED   39 
COMPLETED   38 
NOT COMPLETED   1 
Physician Decision                1 



  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
Treatment
  • nab-paclitaxel 100mg/m2
  • Carboplatin AUC2 (IV)
  • Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks

Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.

Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.

Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.


Baseline Measures
   Treatment 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Years]
Median (Full Range)
 62 
 (46 to 82) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7  17.9% 
Male      32  82.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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      5  12.8% 
White      32  82.1% 
More than one race      0   0.0% 
Unknown or Not Reported      2   5.1% 
Region of Enrollment 
[Units: Participants]
 
United States   39 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical Response Rate Following Induction Chemotherapy   [ Time Frame: 9 weeks ]

2.  Secondary:   Rate of Complete Response Following Induction Chemotherapy   [ Time Frame: Baseline evaluation to 3 weeks after induction chemotherapy ]

3.  Secondary:   Progression Free Survival   [ Time Frame: 1 year ]

4.  Secondary:   Objective Response Rate (CR+PR)   [ Time Frame: 20 weeks ]

5.  Secondary:   Complete Response Rate (CR)   [ Time Frame: 20 weeks ]

6.  Secondary:   Overall Survival   [ Time Frame: 1 year ]

7.  Secondary:   Number of Participants With at Least One Grade 3-4 Toxicity   [ Time Frame: 9 Weeks ]

8.  Secondary:   Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event   [ Time Frame: 24 Weeks ]

9.  Secondary:   Quality of Life   [ Time Frame: screening until one year after treatment ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Robin Johnson
Organization: UNC Lineberger
phone: (919) 966-1125
e-mail: Robin_V_Johnson@med.unc.edu



Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01412229     History of Changes
Other Study ID Numbers: LCCC 1103
Study First Received: August 5, 2011
Results First Received: March 29, 2017
Last Updated: July 5, 2017