Trial Outcomes & Findings for Cetuximab Before Surgery in Treating Patients With Aggressive Locally Advanced Skin Cancer (NCT NCT02324608)
NCT ID: NCT02324608
Last Updated: 2023-12-20
Results Overview
A one-sided Binomial exact test will be used.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2023-12-20
Participant Flow
Participant milestones
| Measure |
Treatment (Cetuximab)
Patients receive cetuximab IV over 60-120 minutes once weekly for 8 weeks.
cetuximab: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cetuximab Before Surgery in Treating Patients With Aggressive Locally Advanced Skin Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Cetuximab)
n=15 Participants
Patients receive cetuximab IV over 60-120 minutes once weekly for 8 weeks.
cetuximab: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsA one-sided Binomial exact test will be used.
Outcome measures
| Measure |
Treatment (Cetuximab)
n=15 Participants
Patients receive cetuximab IV over 60-120 minutes once weekly for 8 weeks.
cetuximab: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Response Rate of Cetuximab by RECIST Criteria
|
15 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsThe estimation of progression-free survival will be performed by the Kaplan-Meier product limit method. Descriptive statistics for all outcome measures will be provided. To evaluate the association between variables, either chi-square test (categorical vs. categorical) or two sample t-test (categorical vs. continuous) or correlation (continuous vs. continuous) will be used depending upon the types of variables in comparison.
Outcome measures
| Measure |
Treatment (Cetuximab)
n=15 Participants
Patients receive cetuximab IV over 60-120 minutes once weekly for 8 weeks.
cetuximab: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Progression-free Survival
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsThe estimation of overall survival will be performed by the Kaplan-Meier product limit method. Descriptive statistics for all outcome measures will be provided. To evaluate the association between variables, either chi-square test (categorical vs. categorical) or two sample t-test (categorical vs. continuous) or correlation (continuous vs. continuous) will be used depending upon the types of variables in comparison.
Outcome measures
| Measure |
Treatment (Cetuximab)
n=15 Participants
Patients receive cetuximab IV over 60-120 minutes once weekly for 8 weeks.
cetuximab: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Survival
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: no data collected
Measure the downstream activation of signaling pathways without a known driver, including the EGFRpathway
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: no data collected
Analyze the relationship of known DNA mutations in tumor per the FoundationOneTM genomic profile, and correlate to clinical endpoints such as clinical benefit and conversion to resectability to discover potential markers of response and/or resistance to cetuximab therapy.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Cetuximab)
Serious events: 2 serious events
Other events: 15 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Treatment (Cetuximab)
n=15 participants at risk
Patients receive cetuximab IV over 60-120 minutes once weekly for 8 weeks.
cetuximab: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Ear and labyrinth disorders
Ear pain
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Infections and infestations
Lung infection
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
Other adverse events
| Measure |
Treatment (Cetuximab)
n=15 participants at risk
Patients receive cetuximab IV over 60-120 minutes once weekly for 8 weeks.
cetuximab: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.0%
6/15 • Number of events 7 • Up to 2 years after the last participant receives treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
33.3%
5/15 • Number of events 8 • Up to 2 years after the last participant receives treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
3/15 • Number of events 3 • Up to 2 years after the last participant receives treatment.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
60.0%
9/15 • Number of events 10 • Up to 2 years after the last participant receives treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
2/15 • Number of events 2 • Up to 2 years after the last participant receives treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Gastrointestinal disorders
Chills
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
13.3%
2/15 • Number of events 2 • Up to 2 years after the last participant receives treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Injury, poisoning and procedural complications
Wound complication
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Vascular disorders
Hypertension
|
20.0%
3/15 • Number of events 6 • Up to 2 years after the last participant receives treatment.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Eye disorders
Eye disorders - Other, specify
|
13.3%
2/15 • Number of events 2 • Up to 2 years after the last participant receives treatment.
|
|
Eye disorders
Dry eye
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
13.3%
2/15 • Number of events 2 • Up to 2 years after the last participant receives treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Gastrointestinal disorders
Esophageal pain
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Gastrointestinal disorders
Oral pain
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Infections and infestations
Rash pustular
|
13.3%
2/15 • Number of events 9 • Up to 2 years after the last participant receives treatment.
|
|
Infections and infestations
Lung infection
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Investigations
Alkaline phosphatase increased
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Investigations
Creatinine increased
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Investigations
Weight loss
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 2 • Up to 2 years after the last participant receives treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
13.3%
2/15 • Number of events 2 • Up to 2 years after the last participant receives treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.7%
1/15 • Number of events 2 • Up to 2 years after the last participant receives treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
6.7%
1/15 • Number of events 3 • Up to 2 years after the last participant receives treatment.
|
|
Ear and labyrinth disorders
Ear pain
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
6.7%
1/15 • Number of events 1 • Up to 2 years after the last participant receives treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place