Trial Outcomes & Findings for Cetuximab in Head and Neck Cancer Patients (NCT NCT03769311)
NCT ID: NCT03769311
Last Updated: 2023-05-24
Results Overview
The tumor size (via clinical measurements) will be measured from the time of diagnosis (pre-CTX) to after treatment with 2 doses of cetuximab and within 48 hours prior to surgery (post-CTX). Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Committee criteria will be used to define clinical response (partial response, progressive disease, or stable disease) prior to surgery.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
up to 42 days
Results posted on
2023-05-24
Participant Flow
Participants were recruited from the University of Wisconsin Carbone Cancer Center from April 2019 to March 2021.
Participant milestones
| Measure |
Pre-Operative Cetuximab Therapy
Two weekly doses of pre-operative cetuximab during the interval between diagnostic HNSCC biopsy and surgery (\~14 days), ensuring that no delay in standard of care (SOC) will occur. For dose #1, participants will receive cetuximab 400 mg/m2 via intravenous infusion over 2 hours (maximum infusion rate 10 mg/min) as per the standard of care loading regimen for cetuximab monotherapy. For dose #2, participants will receive cetuximab 250 mg/m2 via intravenous infusion over 1 hour (maximum infusion rate 10 mg/min) as per the standard of care dosing regimen for cetuximab monotherapy.
Cetuximab: Monoclonal antibody against epidermal growth factor receptor (EGFR)
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|---|---|
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Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Pre-Operative Cetuximab Therapy
Two weekly doses of pre-operative cetuximab during the interval between diagnostic HNSCC biopsy and surgery (\~14 days), ensuring that no delay in standard of care (SOC) will occur. For dose #1, participants will receive cetuximab 400 mg/m2 via intravenous infusion over 2 hours (maximum infusion rate 10 mg/min) as per the standard of care loading regimen for cetuximab monotherapy. For dose #2, participants will receive cetuximab 250 mg/m2 via intravenous infusion over 1 hour (maximum infusion rate 10 mg/min) as per the standard of care dosing regimen for cetuximab monotherapy.
Cetuximab: Monoclonal antibody against epidermal growth factor receptor (EGFR)
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|---|---|
|
Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
Cetuximab in Head and Neck Cancer Patients
Baseline characteristics by cohort
| Measure |
Pre-Operative Cetuximab Therapy
n=15 Participants
Two weekly doses of pre-operative cetuximab during the interval between diagnostic HNSCC biopsy and surgery (\~14 days), ensuring that no delay in standard of care (SOC) will occur. For dose #1, participants will receive cetuximab 400 mg/m2 via intravenous infusion over 2 hours (maximum infusion rate 10 mg/min) as per the standard of care loading regimen for cetuximab monotherapy. For dose #2, participants will receive cetuximab 250 mg/m2 via intravenous infusion over 1 hour (maximum infusion rate 10 mg/min) as per the standard of care dosing regimen for cetuximab monotherapy.
Cetuximab: Monoclonal antibody against epidermal growth factor receptor (EGFR)
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|---|---|
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Age, Customized
20-29
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1 Participants
n=99 Participants
|
|
Age, Customized
30-39
|
1 Participants
n=99 Participants
|
|
Age, Customized
40-49
|
2 Participants
n=99 Participants
|
|
Age, Customized
50-59
|
2 Participants
n=99 Participants
|
|
Age, Customized
60-69
|
6 Participants
n=99 Participants
|
|
Age, Customized
70-79
|
2 Participants
n=99 Participants
|
|
Age, Customized
80-89
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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15 participants
n=99 Participants
|
|
Disease Site
Floor of Mouth
|
3 Participants
n=99 Participants
|
|
Disease Site
Tongue
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8 Participants
n=99 Participants
|
|
Disease Site
Tonsil
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1 Participants
n=99 Participants
|
|
Disease Site
Soft Palate
|
1 Participants
n=99 Participants
|
|
Disease Site
Other, unspecified parts of mouth
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2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 42 daysThe tumor size (via clinical measurements) will be measured from the time of diagnosis (pre-CTX) to after treatment with 2 doses of cetuximab and within 48 hours prior to surgery (post-CTX). Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Committee criteria will be used to define clinical response (partial response, progressive disease, or stable disease) prior to surgery.
Outcome measures
| Measure |
Pre-Operative Cetuximab Therapy
n=15 Participants
Two weekly doses of pre-operative cetuximab during the interval between diagnostic HNSCC biopsy and surgery (\~14 days), ensuring that no delay in standard of care (SOC) will occur. For dose #1, participants will receive cetuximab 400 mg/m2 via intravenous infusion over 2 hours (maximum infusion rate 10 mg/min) as per the standard of care loading regimen for cetuximab monotherapy. For dose #2, participants will receive cetuximab 250 mg/m2 via intravenous infusion over 1 hour (maximum infusion rate 10 mg/min) as per the standard of care dosing regimen for cetuximab monotherapy.
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|---|---|
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Change in Tumor Size
Partial response
|
1 Participants
|
|
Change in Tumor Size
Progressive disease
|
3 Participants
|
|
Change in Tumor Size
Stable disease
|
11 Participants
|
PRIMARY outcome
Timeframe: up to 42 daysThe levels of AXL expression (low vs high, ranges from 0-4+ with 4+ meaning intense staining in the majority of cancer cells and 0 meaning no staining at all) at the time of diagnosis (pre-CTX) will measured and compared to change in the tumor size as reported in Primary Outcome Measure 1.
Outcome measures
| Measure |
Pre-Operative Cetuximab Therapy
n=14 Participants
Two weekly doses of pre-operative cetuximab during the interval between diagnostic HNSCC biopsy and surgery (\~14 days), ensuring that no delay in standard of care (SOC) will occur. For dose #1, participants will receive cetuximab 400 mg/m2 via intravenous infusion over 2 hours (maximum infusion rate 10 mg/min) as per the standard of care loading regimen for cetuximab monotherapy. For dose #2, participants will receive cetuximab 250 mg/m2 via intravenous infusion over 1 hour (maximum infusion rate 10 mg/min) as per the standard of care dosing regimen for cetuximab monotherapy.
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|---|---|
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Objective Tumor Response Rate - AXL Expression
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2.3 score on a scale
Interval 1.0 to 4.0
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SECONDARY outcome
Timeframe: within 28 days after surgeryHospital re-admission for wound healing, surgical complications, or infection that occur within 28 days after surgery will be categorized as definitely related, probably related, possibility related, unlikely related, or unrelated to cetuximab administration and will be reported as a number of participants.
Outcome measures
| Measure |
Pre-Operative Cetuximab Therapy
n=15 Participants
Two weekly doses of pre-operative cetuximab during the interval between diagnostic HNSCC biopsy and surgery (\~14 days), ensuring that no delay in standard of care (SOC) will occur. For dose #1, participants will receive cetuximab 400 mg/m2 via intravenous infusion over 2 hours (maximum infusion rate 10 mg/min) as per the standard of care loading regimen for cetuximab monotherapy. For dose #2, participants will receive cetuximab 250 mg/m2 via intravenous infusion over 1 hour (maximum infusion rate 10 mg/min) as per the standard of care dosing regimen for cetuximab monotherapy.
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|---|---|
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Number of Hospital Re-admission for CTX-related Complications
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0 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: up to 30 monthsSummary statistics of the change in Ki67 (ΔKi67), as established by the surgical specimen, will be reported for the response to cetuximab endpoint.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 30 monthsMarkers include: protein, RNA, circulating tumor cells with CTX response, measured by Ki67. Correlation between ΔKi67 and putative biomarkers will be analyzed as a continuous variable and will be tested using Pearson's correlation coefficient. Correlation between two biomarkers such as AXL and HER3 expression as continuous variables will be investigated using Pearson's correlation coefficient. Summary statistics will be used to report circulating tumor cells at each time point and the changes between time points. The association of change in circulating tumor cells with ΔKi67 (early response) will be explored graphically and with Pearson's correlation coefficient.
Outcome measures
Outcome data not reported
Adverse Events
Pre-Operative Cetuximab Therapy
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pre-Operative Cetuximab Therapy
n=15 participants at risk
Two weekly doses of pre-operative cetuximab during the interval between diagnostic HNSCC biopsy and surgery (\~14 days), ensuring that no delay in standard of care (SOC) will occur. For dose #1, participants will receive cetuximab 400 mg/m2 via intravenous infusion over 2 hours (maximum infusion rate 10 mg/min) as per the standard of care loading regimen for cetuximab monotherapy. For dose #2, participants will receive cetuximab 250 mg/m2 via intravenous infusion over 1 hour (maximum infusion rate 10 mg/min) as per the standard of care dosing regimen for cetuximab monotherapy.
Cetuximab: Monoclonal antibody against epidermal growth factor receptor (EGFR)
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|---|---|
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Skin and subcutaneous tissue disorders
Maculo-papular rash
|
73.3%
11/15 • All AE's will be recorded from the time of informed consent until 28 days past last dose of study drug or day of surgery, whichever is first. SAE's will be recorded from the time of informed consent through 28 days past last dose of study drug or 28 days post-surgery, whichever is later. Up to 10 weeks on study.
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Metabolism and nutrition disorders
Hypomagnesemia
|
6.7%
1/15 • All AE's will be recorded from the time of informed consent until 28 days past last dose of study drug or day of surgery, whichever is first. SAE's will be recorded from the time of informed consent through 28 days past last dose of study drug or 28 days post-surgery, whichever is later. Up to 10 weeks on study.
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Nervous system disorders
Headache
|
26.7%
4/15 • All AE's will be recorded from the time of informed consent until 28 days past last dose of study drug or day of surgery, whichever is first. SAE's will be recorded from the time of informed consent through 28 days past last dose of study drug or 28 days post-surgery, whichever is later. Up to 10 weeks on study.
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Musculoskeletal and connective tissue disorders
Joint Aches
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6.7%
1/15 • All AE's will be recorded from the time of informed consent until 28 days past last dose of study drug or day of surgery, whichever is first. SAE's will be recorded from the time of informed consent through 28 days past last dose of study drug or 28 days post-surgery, whichever is later. Up to 10 weeks on study.
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Musculoskeletal and connective tissue disorders
Muscle Twitching
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6.7%
1/15 • All AE's will be recorded from the time of informed consent until 28 days past last dose of study drug or day of surgery, whichever is first. SAE's will be recorded from the time of informed consent through 28 days past last dose of study drug or 28 days post-surgery, whichever is later. Up to 10 weeks on study.
|
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Gastrointestinal disorders
Nausea
|
20.0%
3/15 • All AE's will be recorded from the time of informed consent until 28 days past last dose of study drug or day of surgery, whichever is first. SAE's will be recorded from the time of informed consent through 28 days past last dose of study drug or 28 days post-surgery, whichever is later. Up to 10 weeks on study.
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General disorders
Fatigue
|
6.7%
1/15 • All AE's will be recorded from the time of informed consent until 28 days past last dose of study drug or day of surgery, whichever is first. SAE's will be recorded from the time of informed consent through 28 days past last dose of study drug or 28 days post-surgery, whichever is later. Up to 10 weeks on study.
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Gastrointestinal disorders
Oral Pain
|
13.3%
2/15 • All AE's will be recorded from the time of informed consent until 28 days past last dose of study drug or day of surgery, whichever is first. SAE's will be recorded from the time of informed consent through 28 days past last dose of study drug or 28 days post-surgery, whichever is later. Up to 10 weeks on study.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Hemorrhage
|
6.7%
1/15 • All AE's will be recorded from the time of informed consent until 28 days past last dose of study drug or day of surgery, whichever is first. SAE's will be recorded from the time of informed consent through 28 days past last dose of study drug or 28 days post-surgery, whichever is later. Up to 10 weeks on study.
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Additional Information
Justine Bruce, MD
University of Wisconsin Carbone Cancer Center
Phone: 608-262-4961
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place