Trial Outcomes & Findings for Cetuximab and Lenalidomide in Head and Neck (NCT NCT01133665)
NCT ID: NCT01133665
Last Updated: 2014-11-24
Results Overview
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.
COMPLETED
PHASE2
42 participants
24 months
2014-11-24
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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)
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Cetuximab and Lenalidomide in Head and Neck
Baseline characteristics by cohort
| Measure |
Cetuximab and Lenalidomide
n=42 Participants
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)
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsProgression-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.
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Correlate the Presence of Specific Fc RIIIa Polymorphisms With Progression-free Survival in Subjects Receiving Cetuximab and Lenalidomide for SCCHN.
|
1.8 months
Interval 1.0 to 11.7
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Fatigue Related to Cetuximab/Lenalidomide
All grades
|
33 participants
|
|
Number of Participants With Fatigue Related to Cetuximab/Lenalidomide
Grade 3-4
|
2 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Maculopapular Rash Related to Cetuximab/Lenalidomide
All grades
|
27 participants
|
|
Number of Participants With Maculopapular Rash Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Constipation Related to Cetuximab/Lenalidomide
All grades
|
16 participants
|
|
Number of Participants With Constipation Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Anemia Related to Cetuximab/Lenalidomide
All grades
|
14 participants
|
|
Number of Participants With Anemia Related to Cetuximab/Lenalidomide
Grade 3-4
|
3 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Anorexia Related to Cetuximab/Lenalidomide
All grades
|
12 participants
|
|
Number of Participants With Anorexia Related to Cetuximab/Lenalidomide
Grade 3-4
|
1 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Nausea Related to Cetuximab/Lenalidomide
All grades
|
10 participants
|
|
Number of Participants With Nausea Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Hypoalbuminemia Related to Cetuximab/Lenalidomide
All grades
|
9 participants
|
|
Number of Participants With Hypoalbuminemia Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Lymphopenia Related to Cetuximab/Lenalidomide
All grades
|
9 participants
|
|
Number of Participants With Lymphopenia Related to Cetuximab/Lenalidomide
Grade 3-4
|
7 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Oral Mucositis Related to Cetuximab/Lenalidomide
All grades
|
9 participants
|
|
Number of Participants With Oral Mucositis Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Pain Related to Cetuximab/Lenalidomide
All grades
|
8 participants
|
|
Number of Participants With Pain Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Vomiting Related to Cetuximab/Lenalidomide
All grades
|
8 participants
|
|
Number of Participants With Vomiting Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With White Blood Cell Decreased Related to Cetuximab/Lenalidomide
All grades
|
8 participants
|
|
Number of Participants With White Blood Cell Decreased Related to Cetuximab/Lenalidomide
Grade 3-4
|
5 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Diarrhea Related to Cetuximab/Lenalidomide
All grades
|
7 participants
|
|
Number of Participants With Diarrhea Related to Cetuximab/Lenalidomide
Grade 3-4
|
1 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Hyponatremia Related to Cetuximab/Lenalidomide
All grades
|
7 participants
|
|
Number of Participants With Hyponatremia Related to Cetuximab/Lenalidomide
Grade 3-4
|
3 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Neutropenia Related to Cetuximab/Lenalidomide
All grades
|
7 participants
|
|
Number of Participants With Neutropenia Related to Cetuximab/Lenalidomide
Grade 3-4
|
6 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Headache Related to Cetuximab/Lenalidomide
All grades
|
6 participants
|
|
Number of Participants With Headache Related to Cetuximab/Lenalidomide
Grade 3-4
|
1 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Hypokalemia Related to Cetuximab/Lenalidomide
All grades
|
6 participants
|
|
Number of Participants With Hypokalemia Related to Cetuximab/Lenalidomide
Grade 3-4
|
1 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Hypophosphatemia Related to Cetuximab/Lenalidomide
All grades
|
6 participants
|
|
Number of Participants With Hypophosphatemia Related to Cetuximab/Lenalidomide
Grade 3-4
|
1 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Thrombocytopenia Related to Cetuximab/Lenalidomide
All grades
|
6 participants
|
|
Number of Participants With Thrombocytopenia Related to Cetuximab/Lenalidomide
Grade 3-4
|
4 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Acneiform Rash Related to Cetuximab/Lenalidomide
All grades
|
6 participants
|
|
Number of Participants With Acneiform Rash Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Hyperglycemia Related to Cetuximab/Lenalidomide
All grades
|
5 participants
|
|
Number of Participants With Hyperglycemia Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Alkaline Phosphatase Increased Related to Cetuximab/Lenalidomide
All grades
|
4 participants
|
|
Number of Participants With Alkaline Phosphatase Increased Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Aspartate Aminotransferase Increased Related to Cetuximab/Lenalidomide
All grades
|
4 participants
|
|
Number of Participants With Aspartate Aminotransferase Increased Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 3
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Xerostomia Related to Cetuximab/Lenalidomide
All grades
|
6 participants
|
|
Number of Participants With Xerostomia Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Fever Related to Cetuximab/Lenalidomide
All grades
|
4 participants
|
|
Number of Participants With Fever Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Hypocalcaemia Related to Cetuximab/Lenalidomide
All grades
|
4 participants
|
|
Number of Participants With Hypocalcaemia Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Neck Pain Related to Cetuximab/Lenalidomide
All grades
|
4 participants
|
|
Number of Participants With Neck Pain Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Peripheral Sensory Neuropathy Related to Cetuximab/Lenalidomide
All grades
|
4 participants
|
|
Number of Participants With Peripheral Sensory Neuropathy Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Alanine Aminotransferase Increased Related to Cetuximab/Lenalidomide
All grades
|
3 participants
|
|
Number of Participants With Alanine Aminotransferase Increased Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Back Pain Related to Cetuximab/Lenalidomide
All grades
|
3 participants
|
|
Number of Participants With Back Pain Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Dyspnea Related to Cetuximab/Lenalidomide
All grades
|
3 participants
|
|
Number of Participants With Dyspnea Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Weight Loss Related to Cetuximab/Lenalidomide
All grades
|
3 participants
|
|
Number of Participants With Weight Loss Related to Cetuximab/Lenalidomide
Grade 3-4
|
0 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Blood Bilirubin Increased Related to Cetuximab/Lenalidomide
All grades
|
2 participants
|
|
Number of Participants With Blood Bilirubin Increased Related to Cetuximab/Lenalidomide
Grade 3-4
|
1 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Infusion Related Reaction Related to Cetuximab/Lenalidomide
All grades
|
2 participants
|
|
Number of Participants With Infusion Related Reaction Related to Cetuximab/Lenalidomide
Grade 3-4
|
1 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With C. Diff Infection Related to Cetuximab/Lenalidomide
All grades
|
1 participants
|
|
Number of Participants With C. Diff Infection Related to Cetuximab/Lenalidomide
Grade 3-4
|
1 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Febrile Neutropenia Related to Cetuximab/Lenalidomide
All grades
|
1 participants
|
|
Number of Participants With Febrile Neutropenia Related to Cetuximab/Lenalidomide
Grade 3-4
|
1 participants
|
SECONDARY outcome
Timeframe: 24 monthPopulation: 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
Toxicity was scored according to NCI/CTC version 4
Outcome measures
| Measure |
Cetuximab and Lenalidomide
n=40 Participants
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)
|
|---|---|
|
Number of Participants With Lymphocyte Count Increased Related to Cetuximab/Lenalidomide
All grades
|
1 participants
|
|
Number of Participants With Lymphocyte Count Increased Related to Cetuximab/Lenalidomide
Grade 3-4
|
1 participants
|
Adverse Events
Cetuximab and Lenalidomide
Serious adverse events
| Measure |
Cetuximab and Lenalidomide
n=40 participants at risk
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)
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.5%
1/40
|
|
Cardiac disorders
Acute coronary syndrome
|
2.5%
1/40
|
|
Cardiac disorders
Chest pain - cardiac
|
2.5%
1/40
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.5%
1/40
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.5%
1/40
|
|
General disorders
Death
|
7.5%
3/40
|
|
General disorders
Fever
|
7.5%
3/40
|
|
General disorders
Infusion related reaction
|
2.5%
1/40
|
|
Infections and infestations
Skin infection
|
2.5%
1/40
|
|
Investigations
INR increased
|
2.5%
1/40
|
|
Investigations
Neutrophil count decreased
|
2.5%
1/40
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
2/40
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.5%
1/40
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.5%
1/40
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.5%
1/40
|
|
Vascular disorders
Thromboembolic event
|
5.0%
2/40
|
Other adverse events
| Measure |
Cetuximab and Lenalidomide
n=40 participants at risk
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)
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign
|
5.0%
2/40
|
|
Nervous system disorders
Dizziness
|
7.5%
3/40
|
|
Nervous system disorders
Headache
|
15.0%
6/40
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
4/40
|
|
Psychiatric disorders
Anxiety
|
5.0%
2/40
|
|
Psychiatric disorders
Insomnia
|
7.5%
3/40
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.0%
2/40
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
6/40
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
8/40
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.0%
2/40
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
2/40
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
2/40
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
15.0%
6/40
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
67.5%
27/40
|
|
Blood and lymphatic system disorders
Anemia
|
37.5%
15/40
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
2/40
|
|
Gastrointestinal disorders
Constipation
|
42.5%
17/40
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
8/40
|
|
Gastrointestinal disorders
Dry mouth
|
15.0%
6/40
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
10/40
|
|
Gastrointestinal disorders
Nausea
|
27.5%
11/40
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
2/40
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
8/40
|
|
General disorders
Facial pain
|
7.5%
3/40
|
|
General disorders
Fatigue
|
82.5%
33/40
|
|
General disorders
Fever
|
15.0%
6/40
|
|
General disorders
Pain
|
20.0%
8/40
|
|
Infections and infestations
Papulopustular rash
|
5.0%
2/40
|
|
Investigations
Alanine aminotransferase increased
|
7.5%
3/40
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
4/40
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
4/40
|
|
Investigations
Blood bilirubin increased
|
5.0%
2/40
|
|
Investigations
Lymphocyte count decreased
|
22.5%
9/40
|
|
Investigations
Neutrophil count decreased
|
15.0%
6/40
|
|
Investigations
Platelet count decreased
|
15.0%
6/40
|
|
Investigations
Weight loss
|
7.5%
3/40
|
|
Investigations
White blood cell decreased
|
20.0%
8/40
|
|
Metabolism and nutrition disorders
Anorexia
|
30.0%
12/40
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
17.5%
7/40
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
22.5%
9/40
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
4/40
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
2/40
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.0%
6/40
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.0%
2/40
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.5%
7/40
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.0%
6/40
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
5/40
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
5/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place