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Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00939627
First received: July 14, 2009
Last updated: August 3, 2015
Last verified: December 2013
Results First Received: July 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Salivary Gland Cancer
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Squamous Cell Carcinoma of the Nasopharynx
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Recurrent Verrucous Carcinoma of the Larynx
Recurrent Verrucous Carcinoma of the Oral Cavity
Salivary Gland Squamous Cell Carcinoma
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Stage IVA Salivary Gland Cancer
Stage IVA Squamous Cell Carcinoma of the Larynx
Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVA Squamous Cell Carcinoma of the Oropharynx
Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IVA Verrucous Carcinoma of the Larynx
Stage IVA Verrucous Carcinoma of the Oral Cavity
Stage IVB Salivary Gland Cancer
Stage IVB Squamous Cell Carcinoma of the Larynx
Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVB Squamous Cell Carcinoma of the Oropharynx
Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IVB Verrucous Carcinoma of the Larynx
Stage IVB Verrucous Carcinoma of the Oral Cavity
Stage IVC Salivary Gland Cancer
Stage IVC Squamous Cell Carcinoma of the Larynx
Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVC Squamous Cell Carcinoma of the Oropharynx
Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IVC Verrucous Carcinoma of the Larynx
Stage IVC Verrucous Carcinoma of the Oral Cavity
Tongue Cancer
Untreated Metastatic Squamous Neck Cancer With Occult Primary
Interventions: Biological: cetuximab
Other: placebo
Drug: sorafenib tosylate
Other: laboratory biomarker analysis
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
Southeast Phase II Consortium (SEP2C) study enrolling participants at seven participating sites during August 2009 through October 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Fifty-five patients were consented and assigned to a treatment arm; 3 withdrew before treatment. Fifty-two patients were treated on study. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.

Reporting Groups
  Description
Arm A - Cetuximab Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility..
Arm B - Cetuximab and Sorafenib Tosylate Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
Participants Who Did Not Receive Treatment. Placebo Arm: The protocol was amended and this arm was removed.

Participant Flow:   Overall Study
    Arm A - Cetuximab     Arm B - Cetuximab and Sorafenib Tosylate     Participants Who Did Not Receive Treatment.  
STARTED     27     28     0  
COMPLETED     0     0     0  
NOT COMPLETED     27     28     0  
Disease Progression                 16                 12                 0  
Adverse Event                 6                 7                 0  
Death                 0                 2                 0  
Withdrawal by Subject                 2                 4                 0  
Other complicating disease                 1                 1                 0  
Not compliant                 2                 0                 0  
No off-tx reason given                 0                 2                 0  



  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.
Baseline participant measures are based on total eligible, consented, patients. Three of 55 consenting patients did not receive treatment. One patient had disease progression before treatment and 2 patients withdrew before treatment, resulting in 52 patients on treatment.

Reporting Groups
  Description
Arm A - Cetuximab Patients were to receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
Arm B - Cetuximab and Sorafenib Tosylate Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.
Total Total of all reporting groups

Baseline Measures
    Arm A - Cetuximab     Arm B - Cetuximab and Sorafenib Tosylate     Total  
Number of Participants  
[units: participants]
  27     28     55  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     21     41  
>=65 years     7     7     14  
Age, Customized  
[units: years]
Median (Full Range)
  59  
  (26 to 74)  
  60  
  (42 to 71)  
  59  
  (26 to 74)  
Gender  
[units: participants]
     
Female     2     5     7  
Male     25     23     48  
Region of Enrollment  
[units: participants]
     
United States     27     28     55  



  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: On‐study date to lesser of date of progression or date of death from any cause (assessed up to 3 years) ]

2.  Secondary:   Best Response   [ Time Frame: On-treatment date to date of disease progression (assessed up to 3 years) ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: On-study date to date of death from any cause (assessed up to 3 years) ]

4.  Secondary:   Number of Participants With Each Worst‐Grade Toxicity   [ Time Frame: On-study date to 30 days following final dose of study drug ]

5.  Other Pre-specified:   Quality of Life   [ Time Frame: up to 3 years ]

6.  Secondary:   Gene Expression Levels   [ Time Frame: Pre-therapy and every 21 days for up to 9 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Overall Survival Associated With Immunomodulatory Cytokines   [ Time Frame: Pre-therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jill Gilbert, M.D.
Organization: Vanderbilt Ingram Cancer Center
phone: 615-343-4677
e-mail: jill.gilbert@vanderbilt.edu


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

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00939627     History of Changes
Other Study ID Numbers: NCI-2012-02847
NCI-2012-02847 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MCC-15780 ( Other Identifier: H. Lee Moffitt Cancer Center and Research Institute )
8070 ( Other Identifier: CTEP )
P30CA076292 ( US NIH Grant/Contract Award Number )
N01CM00100 ( US NIH Grant/Contract Award Number )
Study First Received: July 14, 2009
Results First Received: July 28, 2014
Last Updated: August 3, 2015
Health Authority: United States: Food and Drug Administration