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Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Renato Martins, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00410826
First received: December 11, 2006
Last updated: May 8, 2013
Last verified: May 2013
Results First Received: December 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Stage III Squamous Cell Carcinoma of the Hypopharynx
Stage III Squamous Cell Carcinoma of the Larynx
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Squamous Cell Carcinoma of the Nasopharynx
Stage III Squamous Cell Carcinoma of the Oropharynx
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Larynx
Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Stage IV Squamous Cell Carcinoma of the Oropharynx
Interventions: Drug: erlotinib hydrochloride
Drug: cisplatin
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
Procedure: quality-of-life assessment

  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
Patients were randomized between December 2006 and October 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm A (Cisplatin and Radiotherapy) Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
Arm B (Cisplatin, Radiotherapy, Erlotinib) Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.

Participant Flow:   Overall Study
    Arm A (Cisplatin and Radiotherapy)     Arm B (Cisplatin, Radiotherapy, Erlotinib)  
STARTED     105     99  
COMPLETED     96     95  
NOT COMPLETED     9     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.
204 patients were randomized. However, after completing study therapy, it became apparent that one participant had metastatic disease and was therefore, ineligible for study. This participant was excluded from subsequent results presented here.

Reporting Groups
  Description
Arm A (Cisplatin and Radiotherapy) Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
Arm B (Cisplatin, Radiotherapy, Erlotinib) Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
Total Total of all reporting groups

Baseline Measures
    Arm A (Cisplatin and Radiotherapy)     Arm B (Cisplatin, Radiotherapy, Erlotinib)     Total  
Number of Participants  
[units: participants]
  104     99     203  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     91     86     177  
>=65 years     13     13     26  
Age  
[units: years]
Mean ( Full Range )
  57  
  ( 37 to 74 )  
  56  
  ( 35 to 77 )  
  56  
  ( 35 to 77 )  
Gender  
[units: participants]
     
Female     20     8     28  
Male     84     91     175  
Region of Enrollment  
[units: participants]
     
United States     104     99     203  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm   [ Time Frame: 12 weeks after the completion of therapy ]

2.  Secondary:   Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride   [ Time Frame: Every 3 months for up to 5 years ]

3.  Secondary:   Safety as Assessed Through Summaries of Adverse Events and Laboratory Test Results by Treatment Arm   [ Time Frame: 30 days after the completion of therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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 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: Renato G. Martins, MD, MPH
Organization: University of Washington
phone: 2062882048
e-mail: rgmart@uw.edu


No publications provided by University of Washington

Publications automatically indexed to this study:

Responsible Party: Renato Martins, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00410826     History of Changes
Obsolete Identifiers: NCT01009489
Other Study ID Numbers: 6106, NCI-2009-01546
Study First Received: December 11, 2006
Results First Received: December 14, 2012
Last Updated: May 8, 2013
Health Authority: United States: Institutional Review Board