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Cetuximab and Lenalidomide in Head and Neck

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ClinicalTrials.gov Identifier: NCT01133665
Recruitment Status : Completed
First Posted : May 31, 2010
Results First Posted : November 24, 2014
Last Update Posted : November 24, 2014
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Squamous Cell Carcinoma
Intervention Drug: Cetuximab and Lenalidomide
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description 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)
Period Title: Overall Study
Started 42
Completed 40
Not Completed 2
Reason Not Completed
Physician Decision             2
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description 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)
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 42 participants
59
(42 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
10
  23.8%
Male
32
  76.2%
1.Primary Outcome
Title Correlate the Presence of Specific Fc RIIIa Polymorphisms With Progression-free Survival in Subjects Receiving Cetuximab and Lenalidomide for SCCHN.
Hide Description Progression-free survival (PFS) was defined as time from date of the first treatment dose administered to the earlier of disease progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Median (Full Range)
Unit of Measure: months
1.8
(1.0 to 11.7)
2.Secondary Outcome
Title Number of Participants With Fatigue Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 33
Grade 3-4 2
3.Secondary Outcome
Title Number of Participants With Maculopapular Rash Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 27
Grade 3-4 0
4.Secondary Outcome
Title Number of Participants With Constipation Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 16
Grade 3-4 0
5.Secondary Outcome
Title Number of Participants With Anemia Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 14
Grade 3-4 3
6.Secondary Outcome
Title Number of Participants With Anorexia Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 12
Grade 3-4 1
7.Secondary Outcome
Title Number of Participants With Nausea Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 10
Grade 3-4 0
8.Secondary Outcome
Title Number of Participants With Hypoalbuminemia Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 9
Grade 3-4 0
9.Secondary Outcome
Title Number of Participants With Lymphopenia Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 9
Grade 3-4 7
10.Secondary Outcome
Title Number of Participants With Oral Mucositis Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 9
Grade 3-4 0
11.Secondary Outcome
Title Number of Participants With Pain Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 8
Grade 3-4 0
12.Secondary Outcome
Title Number of Participants With Vomiting Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 8
Grade 3-4 0
13.Secondary Outcome
Title Number of Participants With White Blood Cell Decreased Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 8
Grade 3-4 5
14.Secondary Outcome
Title Number of Participants With Diarrhea Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 7
Grade 3-4 1
15.Secondary Outcome
Title Number of Participants With Hyponatremia Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 7
Grade 3-4 3
16.Secondary Outcome
Title Number of Participants With Neutropenia Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 7
Grade 3-4 6
17.Secondary Outcome
Title Number of Participants With Headache Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 6
Grade 3-4 1
18.Secondary Outcome
Title Number of Participants With Hypokalemia Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 6
Grade 3-4 1
19.Secondary Outcome
Title Number of Participants With Hypophosphatemia Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 6
Grade 3-4 1
20.Secondary Outcome
Title Number of Participants With Thrombocytopenia Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 6
Grade 3-4 4
21.Secondary Outcome
Title Number of Participants With Acneiform Rash Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 6
Grade 3-4 0
22.Secondary Outcome
Title Number of Participants With Hyperglycemia Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 5
Grade 3-4 0
23.Secondary Outcome
Title Number of Participants With Alkaline Phosphatase Increased Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 4
Grade 3-4 0
24.Secondary Outcome
Title Number of Participants With Aspartate Aminotransferase Increased Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 4
Grade 3-4 0
25.Secondary Outcome
Title Number of Participants With Xerostomia Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 3
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 6
Grade 3-4 0
26.Secondary Outcome
Title Number of Participants With Fever Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 4
Grade 3-4 0
27.Secondary Outcome
Title Number of Participants With Hypocalcaemia Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 4
Grade 3-4 0
28.Secondary Outcome
Title Number of Participants With Neck Pain Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 4
Grade 3-4 0
29.Secondary Outcome
Title Number of Participants With Peripheral Sensory Neuropathy Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 4
Grade 3-4 0
30.Secondary Outcome
Title Number of Participants With Alanine Aminotransferase Increased Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 3
Grade 3-4 0
31.Secondary Outcome
Title Number of Participants With Back Pain Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 3
Grade 3-4 0
32.Secondary Outcome
Title Number of Participants With Dyspnea Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 3
Grade 3-4 0
33.Secondary Outcome
Title Number of Participants With Weight Loss Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 3
Grade 3-4 0
34.Secondary Outcome
Title Number of Participants With Blood Bilirubin Increased Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 2
Grade 3-4 1
35.Secondary Outcome
Title Number of Participants With Infusion Related Reaction Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 2
Grade 3-4 1
36.Secondary Outcome
Title Number of Participants With C. Diff Infection Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
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Hide Analysis Population Description
Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 1
Grade 3-4 1
37.Secondary Outcome
Title Number of Participants With Febrile Neutropenia Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 1
Grade 3-4 1
38.Secondary Outcome
Title Number of Participants With Lymphocyte Count Increased Related to Cetuximab/Lenalidomide
Hide Description Toxicity was scored according to NCI/CTC version 4
Time Frame 24 month
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population Description: The number of participants for analysis was determined with >5% incidence of adverse events or any grade 3–4 adverse events related to cetuximab/lenalidomide
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
All grades 1
Grade 3-4 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cetuximab and Lenalidomide
Hide Arm/Group Description 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)
All-Cause Mortality
Cetuximab and Lenalidomide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cetuximab and Lenalidomide
Affected / at Risk (%)
Total   16/40 (40.00%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1/40 (2.50%) 
Cardiac disorders   
Acute coronary syndrome  1/40 (2.50%) 
Chest pain - cardiac  1/40 (2.50%) 
Gastrointestinal disorders   
Oral hemorrhage  1/40 (2.50%) 
Small intestinal obstruction  1/40 (2.50%) 
General disorders   
Death  3/40 (7.50%) 
Fever  3/40 (7.50%) 
Infusion related reaction  1/40 (2.50%) 
Infections and infestations   
Skin infection  1/40 (2.50%) 
Investigations   
INR increased  1/40 (2.50%) 
Neutrophil count decreased  1/40 (2.50%) 
Metabolism and nutrition disorders   
Dehydration  2/40 (5.00%) 
Musculoskeletal and connective tissue disorders   
Bone pain  1/40 (2.50%) 
Generalized muscle weakness  1/40 (2.50%) 
Trismus  1/40 (2.50%) 
Respiratory, thoracic and mediastinal disorders   
Aspiration  1/40 (2.50%) 
Pulmonary edema  1/40 (2.50%) 
Vascular disorders   
Thromboembolic event  2/40 (5.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cetuximab and Lenalidomide
Affected / at Risk (%)
Total   39/40 (97.50%) 
Blood and lymphatic system disorders   
Anemia  15/40 (37.50%) 
Gastrointestinal disorders   
Abdominal pain  2/40 (5.00%) 
Constipation  17/40 (42.50%) 
Diarrhea  8/40 (20.00%) 
Dry mouth  6/40 (15.00%) 
Mucositis oral  10/40 (25.00%) 
Nausea  11/40 (27.50%) 
Oral pain  2/40 (5.00%) 
Vomiting  8/40 (20.00%) 
General disorders   
Facial pain  3/40 (7.50%) 
Fatigue  33/40 (82.50%) 
Fever  6/40 (15.00%) 
Pain  8/40 (20.00%) 
Infections and infestations   
Papulopustular rash  2/40 (5.00%) 
Investigations   
Alanine aminotransferase increased  3/40 (7.50%) 
Alkaline phosphatase increased  4/40 (10.00%) 
Aspartate aminotransferase increased  4/40 (10.00%) 
Blood bilirubin increased  2/40 (5.00%) 
Lymphocyte count decreased  9/40 (22.50%) 
Neutrophil count decreased  6/40 (15.00%) 
Platelet count decreased  6/40 (15.00%) 
Weight loss  3/40 (7.50%) 
White blood cell decreased  8/40 (20.00%) 
Metabolism and nutrition disorders   
Anorexia  12/40 (30.00%) 
Hyperglycemia  7/40 (17.50%) 
Hypoalbuminemia  9/40 (22.50%) 
Hypocalcemia  4/40 (10.00%) 
Hypoglycemia  2/40 (5.00%) 
Hypokalemia  6/40 (15.00%) 
Hypomagnesemia  2/40 (5.00%) 
Hyponatremia  7/40 (17.50%) 
Hypophosphatemia  6/40 (15.00%) 
Musculoskeletal and connective tissue disorders   
Back pain  5/40 (12.50%) 
Neck pain  5/40 (12.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign  2/40 (5.00%) 
Nervous system disorders   
Dizziness  3/40 (7.50%) 
Headache  6/40 (15.00%) 
Peripheral sensory neuropathy  4/40 (10.00%) 
Psychiatric disorders   
Anxiety  2/40 (5.00%) 
Insomnia  3/40 (7.50%) 
Respiratory, thoracic and mediastinal disorders   
Aspiration  2/40 (5.00%) 
Cough  6/40 (15.00%) 
Dyspnea  8/40 (20.00%) 
Sore throat  2/40 (5.00%) 
Skin and subcutaneous tissue disorders   
Alopecia  2/40 (5.00%) 
Dry skin  2/40 (5.00%) 
Rash acneiform  6/40 (15.00%) 
Rash maculo-papular  27/40 (67.50%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Everett Vokes
Organization: The University of Chicago
Phone: 773-702-9306
EMail: evokes@medicine.bsd.uchicago.edu
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01133665     History of Changes
Other Study ID Numbers: 09-206-B
First Submitted: May 27, 2010
First Posted: May 31, 2010
Results First Submitted: November 17, 2014
Results First Posted: November 24, 2014
Last Update Posted: November 24, 2014