Trial Outcomes & Findings for Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC) (NCT NCT00904345)
NCT ID: NCT00904345
Last Updated: 2021-02-24
Results Overview
The ratio (fold change) of tumor EGFR post-loading dose/pre-loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
At baseline (pre-loading dose) and day 7 post-loading dose
Results posted on
2021-02-24
Participant Flow
2 participants withdrew before receiving treatment
Participant milestones
| Measure |
Treatment With Cetuximab + RT
Patients received a single loading dose of cetuximab 400 mg/m (Day 0), then weekly cetuximab 250 mg/m concurrent with radiation. Within approximately 4 days after first (loading) dose of cetuximab, patients received radiation administered as 70 Gy in 35 fractions to the gross tumor, 50-60 Gy to subclinical target volumes.
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|---|---|
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Overall Study
STARTED
|
21
|
|
Overall Study
Stopped or Modified Treatment Due to Toxicity
|
3
|
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Overall Study
COMPLETED
|
18
|
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Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Radiation (RT) Concurrent With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (SCC)
Baseline characteristics by cohort
| Measure |
Treatment: Cetuximab + RT
n=21 Participants
Patients received a single loading dose of cetuximab and a cetuximab infusion delivered once a week during radiotherapy.
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|---|---|
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Age, Continuous
|
65.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Smoking Status
Yes, current
|
7 Participants
n=5 Participants
|
|
Smoking Status
Yes, past
|
13 Participants
n=5 Participants
|
|
Smoking Status
No
|
1 Participants
n=5 Participants
|
|
Cancer Location
Oropharynx
|
16 Participants
n=5 Participants
|
|
Cancer Location
Oral Cavity
|
2 Participants
n=5 Participants
|
|
Cancer Location
Auditory Canal
|
1 Participants
n=5 Participants
|
|
Cancer Location
Hypopharynx
|
1 Participants
n=5 Participants
|
|
Cancer Location
Unknown primary
|
1 Participants
n=5 Participants
|
|
HPV Status
Positive
|
10 Participants
n=5 Participants
|
|
HPV Status
Negative
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6 Participants
n=5 Participants
|
|
HPV Status
Unknown
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline (pre-loading dose) and day 7 post-loading dosePopulation: 15 participants had a sample size sufficient for EGFR analysis.
The ratio (fold change) of tumor EGFR post-loading dose/pre-loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.
Outcome measures
| Measure |
Treatment: Cetuximab + RT
n=15 Participants
Patients received a single loading dose of cetuximab and a cetuximab infusion delivered once a week during radiotherapy.
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|---|---|
|
Mean Change in Tumor Epidermal Growth Factor Receptor (EGFR)
|
0.56 fold change
Interval 0.0 to 1.1
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PRIMARY outcome
Timeframe: At baseline (pre-loading dose) and day 7 post-loading dosePopulation: 10 participants had a sample size sufficient for pEGFR analysis.
The ratio (fold change) of tumor pEGFR post-loading dose/pre-loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.
Outcome measures
| Measure |
Treatment: Cetuximab + RT
n=10 Participants
Patients received a single loading dose of cetuximab and a cetuximab infusion delivered once a week during radiotherapy.
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|---|---|
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Mean Change in Tumor Phosphorylated EGFR (pEGFR)
|
0.81 fold change
Interval 0.0 to 3.0
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PRIMARY outcome
Timeframe: At 1 and 2 yearsPopulation: Patients who completed the full course of cetuximab+RT or had cetuximab+RT stopped for toxicity.
Percentage of participants who survived without recurrent disease, from the time of enrollment to 1 and 2 years.
Outcome measures
| Measure |
Treatment: Cetuximab + RT
n=21 Participants
Patients received a single loading dose of cetuximab and a cetuximab infusion delivered once a week during radiotherapy.
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|---|---|
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Progression Free Survival Rate
1 year
|
47.8 percentage of participants
Interval 29.9 to 76.5
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Progression Free Survival Rate
2 year
|
37.2 percentage of participants
Interval 20.7 to 66.8
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PRIMARY outcome
Timeframe: At 1 and 2 YearsPopulation: Patients who completed the full course of cetuximab+RT or had cetuximab+RT stopped for toxicity.
Percentage of participants alive at 1 and 2 years after enrollment.
Outcome measures
| Measure |
Treatment: Cetuximab + RT
n=21 Participants
Patients received a single loading dose of cetuximab and a cetuximab infusion delivered once a week during radiotherapy.
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|---|---|
|
Overall Survival Rate
1 year
|
68.8 percentage of participants
Interval 50.9 to 93.0
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Overall Survival Rate
2 years
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47.6 percentage of participants
Interval 29.7 to 76.3
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PRIMARY outcome
Timeframe: 3 yearsToxicities are measured by number of participants who experience one or more types or indicator of toxicity, shown as all grades and grades 3-4. As each participant could have multiple toxicities, the total number of incidents outnumbers the number of participants. Toxicities are graded according to the CTCAE v4.
Outcome measures
| Measure |
Treatment: Cetuximab + RT
n=21 Participants
Patients received a single loading dose of cetuximab and a cetuximab infusion delivered once a week during radiotherapy.
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|---|---|
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Number of Participants With Treatment Related Toxicities
All Grades: Cutaneous Toxicity
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16 participants
|
|
Number of Participants With Treatment Related Toxicities
All Grades: Mucositis
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19 participants
|
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Number of Participants With Treatment Related Toxicities
All grades: Dysphagia
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14 participants
|
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Number of Participants With Treatment Related Toxicities
All grades: Hematologic Toxicity
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3 participants
|
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Number of Participants With Treatment Related Toxicities
Grades 3-4: Cutaneous Toxicity
|
4 participants
|
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Number of Participants With Treatment Related Toxicities
Grades 3-4: Mucositis
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8 participants
|
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Number of Participants With Treatment Related Toxicities
Grades 3-4: Dysphagia
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5 participants
|
|
Number of Participants With Treatment Related Toxicities
Grades 3-4: Hematologic Toxicity
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0 participants
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SECONDARY outcome
Timeframe: At baseline (pre-loading dose) and day 7 post-loading dosePopulation: 6 participants had a sample size sufficient for EGFR analysis.
Normal mucosa EGFR was assessed for comparison with EGFR in tumor sample. The fold change in tumor EGFR level at post-loading dose/pre-loading dose of cetuximab, relative to fold change in normal mucosa EGFR level post-loading dose/pre-loading dose of cetuximab was summarized across all participants who had an evaluable tumor sample and normal mucosa sample. The value reported is the ratio of fold change in tumor/fold change in buccal EGFR.
Outcome measures
| Measure |
Treatment: Cetuximab + RT
n=6 Participants
Patients received a single loading dose of cetuximab and a cetuximab infusion delivered once a week during radiotherapy.
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|---|---|
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Change in Tumor EGFR Level Relative to EGFR in Normal Mucosa
|
0.84 ratio
Interval 0.0 to 2.2
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SECONDARY outcome
Timeframe: At baseline (pre-loading dose) and day 7 post-loading dosePopulation: 7 participants had a sample size sufficient for pEGFR analysis.
Normal mucosa pEGFR was assessed for comparison with pEGFR in tumor sample. The fold change in tumor pEGFR level post-loading dose/pre loading dose of cetuximab, relative to fold change in normal mucosa pEGFR level post-loading dose/pre-loading dose of cetuximab was summarized across all participants who had an evaluable tumor sample and normal mucosa sample. The value reported is the ratio of fold change in tumor/fold change in buccal pEGFR.
Outcome measures
| Measure |
Treatment: Cetuximab + RT
n=7 Participants
Patients received a single loading dose of cetuximab and a cetuximab infusion delivered once a week during radiotherapy.
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|---|---|
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Change in Tumor pEGFR Level Relative to pEGFR in Normal Mucosa
|
4.69 ratio
Interval 0.0 to 30.0
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POST_HOC outcome
Timeframe: At 1 and 2 yearsPopulation: Patients who completed the full course of cetuximab+RT or had cetuximab+RT stopped for toxicity.
Percentage of participants without local or regional failure from the time of enrollment to 1 and 2 years.
Outcome measures
| Measure |
Treatment: Cetuximab + RT
n=21 Participants
Patients received a single loading dose of cetuximab and a cetuximab infusion delivered once a week during radiotherapy.
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|---|---|
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Freedom From Local Regional Progression (FFLRP)
1 year
|
63.9 percentage of participants
Interval 44.5 to 92.0
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Freedom From Local Regional Progression (FFLRP)
2 years
|
51.2 percentage of participants
Interval 31.7 to 82.5
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Adverse Events
Treatment: Cetuximab + RT
Serious events: 12 serious events
Other events: 20 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Treatment: Cetuximab + RT
n=21 participants at risk
Patients received a single loading dose of cetuximab and a cetuximab infusion delivered once a week during radiotherapy.
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|---|---|
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Cardiac disorders
Sinus tachycardia
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4.8%
1/21 • Number of events 1 • 3 years
|
|
Cardiac disorders
Ventricular fibrillation
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4.8%
1/21 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Dry mouth
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9.5%
2/21 • Number of events 3 • 3 years
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Gastrointestinal disorders
Dysphagia
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14.3%
3/21 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Esophagitis
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4.8%
1/21 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Unspecified
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
3/21 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Pancreatitis
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
General disorders
Chills
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
General disorders
Fatigue
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
General disorders
Fever
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
General disorders
Multi-organ failure
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9.5%
2/21 • Number of events 2 • 3 years
|
|
Infections and infestations
Skin infection
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4.8%
1/21 • Number of events 1 • 3 years
|
|
Infections and infestations
Tracheitis
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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14.3%
3/21 • Number of events 3 • 3 years
|
|
Psychiatric disorders
Delirium
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4.8%
1/21 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Psychiatric disorders - Unspecified
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Treatment: Cetuximab + RT
n=21 participants at risk
Patients received a single loading dose of cetuximab and a cetuximab infusion delivered once a week during radiotherapy.
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|---|---|
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Blood and lymphatic system disorders
Anemia
|
14.3%
3/21 • Number of events 6 • 3 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Unspecified
|
9.5%
2/21 • Number of events 5 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
19.0%
4/21 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
2/21 • Number of events 3 • 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
90.5%
19/21 • Number of events 50 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
76.2%
16/21 • Number of events 49 • 3 years
|
|
Gastrointestinal disorders
Esophagitis
|
76.2%
16/21 • Number of events 24 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Unspecified
|
14.3%
3/21 • Number of events 6 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
95.2%
20/21 • Number of events 52 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
7/21 • Number of events 9 • 3 years
|
|
Gastrointestinal disorders
Oral pain
|
19.0%
4/21 • Number of events 5 • 3 years
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
42.9%
9/21 • Number of events 33 • 3 years
|
|
Gastrointestinal disorders
Stomach pain
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
2/21 • Number of events 3 • 3 years
|
|
General disorders
Chills
|
9.5%
2/21 • Number of events 2 • 3 years
|
|
General disorders
Fatigue
|
33.3%
7/21 • Number of events 7 • 3 years
|
|
General disorders
Fever
|
9.5%
2/21 • Number of events 2 • 3 years
|
|
General disorders
Pain
|
9.5%
2/21 • Number of events 3 • 3 years
|
|
Infections and infestations
Papulopustular rash
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
81.0%
17/21 • Number of events 35 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Investigations
Blood bilirubin increased
|
4.8%
1/21 • Number of events 4 • 3 years
|
|
Investigations
Creatinine increased
|
4.8%
1/21 • Number of events 2 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
14.3%
3/21 • Number of events 6 • 3 years
|
|
Investigations
Platelet count decreased
|
4.8%
1/21 • Number of events 4 • 3 years
|
|
Investigations
Weight loss
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Investigations
White blood cell decreased
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
47.6%
10/21 • Number of events 17 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.5%
2/21 • Number of events 5 • 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
9.5%
2/21 • Number of events 2 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.8%
1/21 • Number of events 2 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
28.6%
6/21 • Number of events 11 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
90.5%
19/21 • Number of events 48 • 3 years
|
|
Nervous system disorders
Facial muscle weakness
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Nervous system disorders
Headache
|
9.5%
2/21 • Number of events 2 • 3 years
|
|
Nervous system disorders
Myelitis
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Nervous system disorders
Paresthesia
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Anxiety
|
9.5%
2/21 • Number of events 2 • 3 years
|
|
Psychiatric disorders
Insomnia
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Psychiatric disorders - Unspecified
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.5%
2/21 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
14.3%
3/21 • Number of events 3 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
38.1%
8/21 • Number of events 15 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
47.6%
10/21 • Number of events 16 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Unspecified
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
4.8%
1/21 • Number of events 1 • 3 years
|
|
Vascular disorders
Hot flashes
|
4.8%
1/21 • Number of events 1 • 3 years
|
Additional Information
Shruti Jolly, M.D.
University of Michigan Rogel Cancer Center
Phone: 734-936-4302
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place