Trial Outcomes & Findings for Determine Tumor Response Using Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) Before and After Cetuximab in Patients With Head and Neck Cancer (NCT NCT00671437)
NCT ID: NCT00671437
Last Updated: 2017-03-14
Results Overview
FDG-PET/CT images were evaluated qualitatively as well as quantitatively by one of two experienced nuclear radiologists. For quantitative analysis, SUVmax within each of the metastatic tumor sites was determined within a volume of interest around the tumor using a Siemens eSoft workstation. Up to a maximum of three target lesions(\>= 1.5 cm on the baseline CT) were identified as target lesions on the baseline FDG-PET. When multiple lesions were present, those having the greatest FDG uptake on the baseline FDG-PET were selected as target lesions. Lesions containing areas of necrosis were avoided. Other metabolically active lesions and lesions that were \<1.5 cm on CT were considered non-target lesions. When more than one target lesion was identified, the average percentage change in SUVmax was used to determine metabolic response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Baseline and after 8 weeks of treatment
Results posted on
2017-03-14
Participant Flow
Recruitment was open from 06/03/08-10/17/11 at the Siteman Cancer Center (a medical clinic).
Participant milestones
| Measure |
Arm 1 (Cetuximab)
Whole body Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Arm 1 (Cetuximab)
Whole body Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease
|
|---|---|
|
Overall Study
Progressive disease before C1 week 8
|
8
|
|
Overall Study
Cutaneous SCC of head and neck
|
3
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Ineligible post-hoc
|
1
|
Baseline Characteristics
Determine Tumor Response Using Fluorodeoxyglucose (FDG)- Positron Emission Tomography (PET)/Computed Tomography (CT) Before and After Cetuximab in Patients With Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Arm 1 (Cetuximab)
n=27 Participants
Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
|
Performance Status
Performance Status 0
|
5 participants
n=5 Participants
|
|
Performance Status
Performance Status 1
|
13 participants
n=5 Participants
|
|
Performance Status
Performance Status 2
|
9 participants
n=5 Participants
|
|
Smoking history
Yes
|
24 participants
n=5 Participants
|
|
Smoking history
No
|
3 participants
n=5 Participants
|
|
Primary Tumor Site
Oral cavity
|
10 participants
n=5 Participants
|
|
Primary Tumor Site
Oropharynx
|
8 participants
n=5 Participants
|
|
Primary Tumor Site
Larynx
|
4 participants
n=5 Participants
|
|
Primary Tumor Site
Hypopharynx
|
5 participants
n=5 Participants
|
|
Prior Cetuximab Exposure
Yes
|
8 participants
n=5 Participants
|
|
Prior Cetuximab Exposure
No
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and after 8 weeks of treatmentFDG-PET/CT images were evaluated qualitatively as well as quantitatively by one of two experienced nuclear radiologists. For quantitative analysis, SUVmax within each of the metastatic tumor sites was determined within a volume of interest around the tumor using a Siemens eSoft workstation. Up to a maximum of three target lesions(\>= 1.5 cm on the baseline CT) were identified as target lesions on the baseline FDG-PET. When multiple lesions were present, those having the greatest FDG uptake on the baseline FDG-PET were selected as target lesions. Lesions containing areas of necrosis were avoided. Other metabolically active lesions and lesions that were \<1.5 cm on CT were considered non-target lesions. When more than one target lesion was identified, the average percentage change in SUVmax was used to determine metabolic response.
Outcome measures
| Measure |
Arm 1 (Cetuximab)
n=27 Participants
Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease
|
Stable Metabolic Disease (Overall PET Response)
|
Progressive Metabolic Disease (Overall PET Response)
|
Total (Overall PET Response)
|
|---|---|---|---|---|
|
Metabolic Response of Target Lesions Assessed as the Change in Standardized Uptake Values (SUV) Max on FDG-PET/CT
|
-21 percentage of change
Interval -81.0 to 72.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and after 8 weeks of treatmentEight weeks of treatment is equal to one cycle of treatment. FDG-PET/CT images were evaluated qualitatively as well as quantitatively by one of two experienced nuclear radiologists. For quantitative analysis, SUVmax within each of the metastatic tumor sites was determined within a volume of interest around the tumor using a Siemens eSoft workstation. Up to a maximum of three target lesions(\>= 1.5 cm on the baseline CT) were identified as target lesions on the baseline FDG-PET. When multiple lesions were present, those having the greatest FDG uptake on the baseline FDG-PET were selected as target lesions. Lesions containing areas of necrosis were avoided. Other metabolically active lesions and lesions that were \<1.5 cm on CT were considered non-target lesions. When more than one target lesion was identified, the average percentage change in SUVmax was used to determine metabolic response.
Outcome measures
| Measure |
Arm 1 (Cetuximab)
n=27 Participants
Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease
|
Stable Metabolic Disease (Overall PET Response)
|
Progressive Metabolic Disease (Overall PET Response)
|
Total (Overall PET Response)
|
|---|---|---|---|---|
|
SUVmax at up to Three Target Tumor Sites as Assessed by FDG-PET/CT of Eligible Patients at Baseline and Then After Eight Weeks of Treatment With Cetuximab.
Pre-Cetuximab
|
9.3 SUVmax
Interval 7.2 to 12.1
|
—
|
—
|
—
|
|
SUVmax at up to Three Target Tumor Sites as Assessed by FDG-PET/CT of Eligible Patients at Baseline and Then After Eight Weeks of Treatment With Cetuximab.
Post Cycle 1
|
7.3 SUVmax
Interval 5.6 to 9.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After 8 weeks of treatmentDefinitions of metabolic response by FDG-PET/CT included: complete metabolic response(CMR)-complete resolution of all metabolically active target and non-target lesions, and no new lesions; partial metabolic response(PMR)-20% or greater decrease in SUV of target lesions with or without decrease in number/size of non-target lesions, and no new lesions; progressive metabolic disease(PMD)-one or more new lesions, 20% or greater increase in SUV of target lesions and/or unequivocal increase in FDG activity of non-target lesions; and stable metabolic disease(SMD)-not qualifying as CMR, PMR, or PMD.
Outcome measures
| Measure |
Arm 1 (Cetuximab)
n=27 Participants
Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease
|
Stable Metabolic Disease (Overall PET Response)
|
Progressive Metabolic Disease (Overall PET Response)
|
Total (Overall PET Response)
|
|---|---|---|---|---|
|
Overall Tumor Metabolic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by FDG-PET/CT
PMR/SMD
|
15 participants
|
—
|
—
|
—
|
|
Overall Tumor Metabolic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by FDG-PET/CT
PMD
|
12 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After 8 weeks of treatmentDefinitions of anatomic response by RECIST for CT scan included: complete response(CR)-disappearance of all target and non-target lesions and no new lesions; partial response(PR)-at least 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter, persistence of one or more non-target lesions, and no new lesions; stable disease (SD)-neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started, persistence of one or more non-target lesions, and no new lesions; progressive disease(PD)-at least a 20% increase in the sum of the longest diameter of target lesions recorded since the treatment started, appearance of one or more new lesions/unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Arm 1 (Cetuximab)
n=27 Participants
Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease
|
Stable Metabolic Disease (Overall PET Response)
|
Progressive Metabolic Disease (Overall PET Response)
|
Total (Overall PET Response)
|
|---|---|---|---|---|
|
Overall Anatomic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by CT Scan
Partial Response/Stable Disease
|
20 participants
|
—
|
—
|
—
|
|
Overall Anatomic Response to Eight Weeks of Scheduled Weekly Doses of Cetuximab as Assessed by CT Scan
Progressive Disease
|
7 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After 8 weeks of treatmentA generalization of McNemar's test was used to test for concordance of response(partial, stable or progression) by CT and by FDG-PET/CT.
Outcome measures
| Measure |
Arm 1 (Cetuximab)
n=10 Participants
Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease
|
Stable Metabolic Disease (Overall PET Response)
n=5 Participants
|
Progressive Metabolic Disease (Overall PET Response)
n=12 Participants
|
Total (Overall PET Response)
n=27 Participants
|
|---|---|---|---|---|
|
Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination
Partial Response (overall CT response)
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination
Stable Disease (overall CT response)
|
9 participants
|
5 participants
|
5 participants
|
19 participants
|
|
Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination
Progressive Disease (overall CT response)
|
0 participants
|
0 participants
|
7 participants
|
7 participants
|
|
Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination
Total (overall CT response)
|
10 participants
|
5 participants
|
12 participants
|
27 participants
|
SECONDARY outcome
Timeframe: After 8 weeks of treatmentAgreement in treatment decision using CT and FDG-PET/CT. Agreement in treatment decision occurred when tumor response by CT and FDG-PET/CT resulted in the same decision in treatment (continue cetuximab due to disease control or stop cetuximab due to progression). Disagreement in treatment decision occurred when tumor response assessment by CT and FDG-PET/CT resulted in different treatment decisions.
Outcome measures
| Measure |
Arm 1 (Cetuximab)
n=27 Participants
Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease
|
Stable Metabolic Disease (Overall PET Response)
|
Progressive Metabolic Disease (Overall PET Response)
|
Total (Overall PET Response)
|
|---|---|---|---|---|
|
Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination
Treatment Agreement
|
22 participants
|
—
|
—
|
—
|
|
Correlation of Overall Tumor Metabolic Response as Assessed by FDG-PET/CT With the Anatomic Tumor Response Rate by RECIST Criteria as Assessed by CT and Clinical Examination
Treatment Disagreement
|
5 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks until disease progression (up to 1 year)Outcome measures
| Measure |
Arm 1 (Cetuximab)
n=27 Participants
Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease
|
Stable Metabolic Disease (Overall PET Response)
|
Progressive Metabolic Disease (Overall PET Response)
|
Total (Overall PET Response)
|
|---|---|---|---|---|
|
Overall Best Anatomic Tumor Response Rate to Cetuximab Given Until Disease Progression as Assessed by RECIST Criteria Using CT & Clinical Examination
Partial Response
|
1 participants
|
—
|
—
|
—
|
|
Overall Best Anatomic Tumor Response Rate to Cetuximab Given Until Disease Progression as Assessed by RECIST Criteria Using CT & Clinical Examination
Stable Disease
|
20 participants
|
—
|
—
|
—
|
|
Overall Best Anatomic Tumor Response Rate to Cetuximab Given Until Disease Progression as Assessed by RECIST Criteria Using CT & Clinical Examination
Progressive Disease
|
7 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks until disease progression (up to 1 year)Cetuximab was continued after cycle 1 in patients with disease control(PR/SD) by CT, even if the FDG-PET/CT showed PMD. Cetuximab was discontinued after cycle 1 in patients with progression by CT.
Outcome measures
| Measure |
Arm 1 (Cetuximab)
n=15 Participants
Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease
|
Stable Metabolic Disease (Overall PET Response)
n=5 Participants
|
Progressive Metabolic Disease (Overall PET Response)
n=7 Participants
|
Total (Overall PET Response)
|
|---|---|---|---|---|
|
Correlate the Overall Tumor Metabolic Response and Overall Anatomic Tumor Response and Clinical Examination Obtained at Baseline and After Eight Weeks of Treatment With Cetuximab to Time to Progression (TTP) With Cetuximab Therapy
|
166 days
Interval 86.0 to 217.0
|
105 days
Interval 66.0 to 159.0
|
53 days
Interval 49.0 to 56.0
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks until death (approximately 5 years)Population: The small dataset precluded an adequate analysis of overall survival relationships due to varying co-variates such as post-progression therapies, ECOG PS, co-morbidities.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 8 weeks until death (approximately 5 years)Population: This was not analyzed due to the lack of evidence-based medicine showing an overall survival benefit of cetuximab monotherapy in this type of cancer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 days after end of study treatment (approximately 1 year after start of treatment)Outcome measures
| Measure |
Arm 1 (Cetuximab)
n=27 Participants
Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease
|
Stable Metabolic Disease (Overall PET Response)
|
Progressive Metabolic Disease (Overall PET Response)
|
Total (Overall PET Response)
|
|---|---|---|---|---|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Allergic reaction/hypersensitivity
|
5 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Hypotension
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
INR
|
9 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
PTT
|
8 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Fever
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Fatigue
|
15 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Insomnia
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Rigors
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Weight loss
|
7 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Failure to thrive
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Death - progression
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Alopecia
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Bruising - port site
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Bruising - thigh
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Rash/desquamation
|
3 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Chelitis
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Dry skin
|
7 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Rash - acneiform
|
28 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Rash - trach site
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Anorexia
|
3 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Constipation
|
7 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Dehydration
|
2 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Diarrhea
|
5 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Dry mouth
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Dysphagia
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Mucositis
|
4 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Nausea
|
13 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Taste alteration
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Vomiting
|
2 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Hemoglobin
|
21 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Leukopenia
|
3 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Lymphopenia
|
27 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Platelets
|
2 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Hemorrhage: nose
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Hemorrhage: oral cavity
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Hemorrhage: pulmonary
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Hemorrhage: tumor site
|
3 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Alkaline phosphatase
|
6 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Bilirubin
|
3 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
SGOT (AST)
|
6 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
SGPT (ALT)
|
9 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Infection without neutropenia
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Infection normal ANC - cellulitis
|
2 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Infection normal ANC - left neck wound
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Infection normal ANC - sinus
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Infection normal ANC - scalp drainage Ecoli
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Infection normal ANC - scalp wound
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Infection normal ANC - skin
|
3 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Infection normal ANC - staph shingles
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Infection normal ANC - tumor
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Infection normal ANC - upper respiratory
|
2 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Infection normal ANC - urinary tract infection
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Infection normal ANC - yeast
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Infection lung - pneumonia
|
2 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Infection skin - ungual
|
9 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Edema - eye
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Edema - head & neck
|
2 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Edema - limb
|
4 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Albumin - low
|
26 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Calcium - low
|
18 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Calcium - high
|
2 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Glucose - low
|
3 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Glucose - high
|
9 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Magnesium - low
|
14 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Magnesium - high
|
2 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Phosphorus - low
|
3 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Potassium - low
|
8 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Potassium - high
|
5 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Sodium - low
|
14 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Sodium - high
|
5 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Fracture
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Brachial plexophathy
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Mood alteration - anxiety
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Mood alteration - depression
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Restless leg
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Syncope
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Back pain
|
2 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Headache
|
2 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Neck pain
|
3 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Tumor pain
|
5 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Aspiration
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Bronchospasm/wheezing
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Cough
|
2 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Dyspnea
|
4 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Hypoxia
|
2 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Voice changes/dysarthria
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Creatinine
|
9 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Diuresis
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Dry eye syndrome
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Thrombosis
|
1 participants
|
—
|
—
|
—
|
|
Assess the Toxicity Profile for Standard of Care Cetuximab Given to Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck
Trismus
|
1 participants
|
—
|
—
|
—
|
Adverse Events
Arm 1 (Cetuximab)
Serious events: 7 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 (Cetuximab)
n=42 participants at risk
Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Brachial plexopathy
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm/Wheezing
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Death - Disease Progression
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Infection lung - pneumonia
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Lymphocytes (decreased)
|
2.4%
1/42 • Number of events 1
|
Other adverse events
| Measure |
Arm 1 (Cetuximab)
n=42 participants at risk
Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)
Cetuximab 400 mg/m2 IV over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.
Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)
Cetuximab 250 mg/m2 IV over 1 hour on Day 57
Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease
|
|---|---|
|
Metabolism and nutrition disorders
Albumin (low)
|
61.9%
26/42
|
|
Investigations
Alkaline phosphatase (high)
|
14.3%
6/42
|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
9.5%
4/42
|
|
Metabolism and nutrition disorders
Anorexia
|
7.1%
3/42
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
4.8%
2/42
|
|
Metabolism and nutrition disorders
Calcium (high)
|
4.8%
2/42
|
|
Metabolism and nutrition disorders
Calcium (low)
|
42.9%
18/42
|
|
Gastrointestinal disorders
Constipation
|
16.7%
7/42
|
|
Investigations
Creatinine (high)
|
21.4%
9/42
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
2/42
|
|
Gastrointestinal disorders
Diarrhea
|
11.9%
5/42
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
7/42
|
|
General disorders
Edema - head and neck
|
4.8%
2/42
|
|
General disorders
Edema - limb
|
9.5%
4/42
|
|
General disorders
Fatigue
|
35.7%
15/42
|
|
Metabolism and nutrition disorders
Glucose (high)
|
21.4%
9/42
|
|
Metabolism and nutrition disorders
Glucose (low)
|
7.1%
3/42
|
|
Nervous system disorders
Headache
|
4.8%
2/42
|
|
Blood and lymphatic system disorders
Hemoglobin (low)
|
50.0%
21/42
|
|
Vascular disorders
Hemorrhage: Tumor Site
|
7.1%
3/42
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
2/42
|
|
Investigations
INR (high)
|
21.4%
9/42
|
|
Infections and infestations
Infection normal ANC - cellulitis
|
4.8%
2/42
|
|
Infections and infestations
Infection normal ANC - skin
|
7.1%
3/42
|
|
Infections and infestations
Infection normal ANC - upper respiratory
|
4.8%
2/42
|
|
Infections and infestations
Infection skin - ungual
|
21.4%
9/42
|
|
Investigations
Leukocytes (low)
|
7.1%
3/42
|
|
Investigations
Lymphocytes (low)
|
61.9%
26/42
|
|
Metabolism and nutrition disorders
Magnesium (high)
|
4.8%
2/42
|
|
Metabolism and nutrition disorders
Magnesium (low)
|
33.3%
14/42
|
|
Gastrointestinal disorders
Mucositis
|
9.5%
4/42
|
|
Gastrointestinal disorders
Nausea
|
31.0%
13/42
|
|
Investigations
PTT (high)
|
19.0%
8/42
|
|
Musculoskeletal and connective tissue disorders
Pain - back
|
4.8%
2/42
|
|
Musculoskeletal and connective tissue disorders
Pain - musculoskeletal - neck
|
7.1%
3/42
|
|
Metabolism and nutrition disorders
Phosphate (low)
|
7.1%
3/42
|
|
Investigations
Platelets (low)
|
4.8%
2/42
|
|
Metabolism and nutrition disorders
Potassium (low)
|
19.0%
8/42
|
|
Skin and subcutaneous tissue disorders
Rach - acneiform
|
66.7%
28/42
|
|
Skin and subcutaneous tissue disorders
Rash - trach site
|
4.8%
2/42
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
7.1%
3/42
|
|
Investigations
SGOT (AST - high)
|
14.3%
6/42
|
|
Investigations
SGPT (ALT-high)
|
21.4%
9/42
|
|
Metabolism and nutrition disorders
Sodium (high)
|
11.9%
5/42
|
|
Metabolism and nutrition disorders
Sodium (low)
|
33.3%
14/42
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
2/42
|
|
Investigations
Weight loss
|
16.7%
7/42
|
|
Metabolism and nutrition disorders
Potassium (high)
|
11.9%
5/42
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain - tumor
|
11.9%
5/42
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
2/42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
9.5%
4/42
|
Additional Information
Dr. Douglas R. Adkins
Washington University School of Medicine
Phone: 314-362-5654
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place