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Cetuximab and Lenalidomide in Head and Neck

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01133665
First received: May 27, 2010
Last updated: November 17, 2014
Last verified: November 2014
Results First Received: November 17, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Squamous Cell Carcinoma
Intervention: Drug: Cetuximab and Lenalidomide

  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
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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
Cetuximab and Lenalidomide Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)

Participant Flow:   Overall Study
    Cetuximab and Lenalidomide  
STARTED     42  
COMPLETED     40  
NOT COMPLETED     2  
Physician Decision                 2  



  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
Cetuximab and Lenalidomide Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)

Baseline Measures
    Cetuximab and Lenalidomide  
Number of Participants  
[units: participants]
  42  
Age  
[units: years]
Median ( Full Range )
  59  
  ( 42 to 82 )  
Gender  
[units: participants]
 
Female     10  
Male     32  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Correlate the Presence of Specific Fc RIIIa Polymorphisms With Progression-free Survival in Subjects Receiving Cetuximab and Lenalidomide for SCCHN.   [ Time Frame: 24 months ]

2.  Secondary:   Number of Participants With Fatigue Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

3.  Secondary:   Number of Participants With Maculopapular Rash Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

4.  Secondary:   Number of Participants With Constipation Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

5.  Secondary:   Number of Participants With Anemia Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

6.  Secondary:   Number of Participants With Anorexia Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

7.  Secondary:   Number of Participants With Nausea Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

8.  Secondary:   Number of Participants With Hypoalbuminemia Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

9.  Secondary:   Number of Participants With Lymphopenia Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

10.  Secondary:   Number of Participants With Oral Mucositis Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

11.  Secondary:   Number of Participants With Pain Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

12.  Secondary:   Number of Participants With Vomiting Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

13.  Secondary:   Number of Participants With White Blood Cell Decreased Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

14.  Secondary:   Number of Participants With Diarrhea Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

15.  Secondary:   Number of Participants With Hyponatremia Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

16.  Secondary:   Number of Participants With Neutropenia Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

17.  Secondary:   Number of Participants With Headache Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

18.  Secondary:   Number of Participants With Hypokalemia Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

19.  Secondary:   Number of Participants With Hypophosphatemia Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

20.  Secondary:   Number of Participants With Thrombocytopenia Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

21.  Secondary:   Number of Participants With Acneiform Rash Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

22.  Secondary:   Number of Participants With Hyperglycemia Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

23.  Secondary:   Number of Participants With Alkaline Phosphatase Increased Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

24.  Secondary:   Number of Participants With Aspartate Aminotransferase Increased Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

25.  Secondary:   Number of Participants With Xerostomia Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

26.  Secondary:   Number of Participants With Fever Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

27.  Secondary:   Number of Participants With Hypocalcaemia Related to Cetuximab/Lenalidomide   [ Time Frame: 24 months ]

28.  Secondary:   Number of Participants With Neck Pain Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

29.  Secondary:   Number of Participants With Peripheral Sensory Neuropathy Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

30.  Secondary:   Number of Participants With Alanine Aminotransferase Increased Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

31.  Secondary:   Number of Participants With Back Pain Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

32.  Secondary:   Number of Participants With Dyspnea Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

33.  Secondary:   Number of Participants With Weight Loss Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

34.  Secondary:   Number of Participants With Blood Bilirubin Increased Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

35.  Secondary:   Number of Participants With Infusion Related Reaction Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

36.  Secondary:   Number of Participants With C. Diff Infection Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

37.  Secondary:   Number of Participants With Febrile Neutropenia Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]

38.  Secondary:   Number of Participants With Lymphocyte Count Increased Related to Cetuximab/Lenalidomide   [ Time Frame: 24 month ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Everett Vokes
Organization: The University of Chicago
phone: 773-702-9306
e-mail: evokes@medicine.bsd.uchicago.edu


No publications provided


Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01133665     History of Changes
Other Study ID Numbers: 09-206-B
Study First Received: May 27, 2010
Results First Received: November 17, 2014
Last Updated: November 17, 2014
Health Authority: United States: Food and Drug Administration