Trial Outcomes & Findings for Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib (NCT NCT00716456)
NCT ID: NCT00716456
Last Updated: 2015-04-30
Results Overview
To determine the maximum tolerated dose (MTD) of cetuximab given every 2 weeks in patients with lung adenocarcinoma receiving erlotinib that have developed acquired resistance to erlotinib (phase I portion)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
At conclusion of study, up to 24 weeks
Results posted on
2015-04-30
Participant Flow
Protocol Open to Accrual: 7/15/2008 Protocol Closed to Accrual: 5/25/2010 Primary Completion Date: 5/24/2011 Recruitment Location is the Medical Clinic
Participant milestones
| Measure |
Cetuximab 250 mg/m2
Cetuximab 250 mg/m2 IV every two weeks
|
Cetuximab 375 mg/m2
Cetuximab 375 mg/m2 IV every two weeks
|
Cetuximab 500 mg/m2
Cetuximab 500 mg/m2 IV every two weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
13
|
|
Overall Study
COMPLETED
|
3
|
3
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Cetuximab 250 mg/m2
Cetuximab 250 mg/m2 IV every two weeks
|
Cetuximab 375 mg/m2
Cetuximab 375 mg/m2 IV every two weeks
|
Cetuximab 500 mg/m2
Cetuximab 500 mg/m2 IV every two weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
Baseline Characteristics
Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib
Baseline characteristics by cohort
| Measure |
Cetuximab 250 mg/m2
n=3 Participants
Cetuximab 250 mg/m2 IV every two weeks
|
Cetuximab 375 mg/m2
n=5 Participants
Cetuximab 375 mg/m2 IV every two weeks
|
Cetuximab 500 mg/m2
n=13 Participants
Cetuximab 500 mg/m2 IV every two weeks
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
21 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At conclusion of study, up to 24 weeksTo determine the maximum tolerated dose (MTD) of cetuximab given every 2 weeks in patients with lung adenocarcinoma receiving erlotinib that have developed acquired resistance to erlotinib (phase I portion)
Outcome measures
| Measure |
Cetuximab 250 mg/m2
n=3 Participants
Cetuximab 250 mg/m2 IV every two weeks
|
Cetuximab 375 mg/m2
n=5 Participants
Cetuximab 375 mg/m2 IV every two weeks
|
Cetuximab 500 mg/m2
n=13 Participants
Cetuximab 500 mg/m2 IV every two weeks
|
|---|---|---|---|
|
The Maximum Tolerated Dose (MTD) of Cetuximab Given Every 2 Weeks
|
500 mg/m2 of CETUXIMAB
|
500 mg/m2 of CETUXIMAB
|
500 mg/m2 of CETUXIMAB
|
Adverse Events
Cetuximab 250 mg/m2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Cetuximab 375 mg/m2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cetuximab 500 mg/m2
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab 250 mg/m2
n=3 participants at risk
Cetuximab 250 mg/m2 IV every two weeks
|
Cetuximab 375 mg/m2
n=5 participants at risk
Cetuximab 375 mg/m2 IV every two weeks
|
Cetuximab 500 mg/m2
n=13 participants at risk
Cetuximab 500 mg/m2 IV every two weeks
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/13
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/13
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
0.00%
0/13
|
|
Immune system disorders
Allergic reaction/Hypersensitivity
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/13
|
|
General disorders
Fatigue
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/13
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
0.00%
0/13
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3
|
0.00%
0/5
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/3
|
0.00%
0/5
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3
|
0.00%
0/5
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Gait disturbance
|
0.00%
0/3
|
0.00%
0/5
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3
|
0.00%
0/5
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/3
|
0.00%
0/5
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
0.00%
0/5
|
7.7%
1/13 • Number of events 2
|
|
General disorders
Pain
|
0.00%
0/3
|
0.00%
0/5
|
7.7%
1/13 • Number of events 1
|
Other adverse events
| Measure |
Cetuximab 250 mg/m2
n=3 participants at risk
Cetuximab 250 mg/m2 IV every two weeks
|
Cetuximab 375 mg/m2
n=5 participants at risk
Cetuximab 375 mg/m2 IV every two weeks
|
Cetuximab 500 mg/m2
n=13 participants at risk
Cetuximab 500 mg/m2 IV every two weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 2
|
53.8%
7/13 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/3
|
20.0%
1/5 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
0.00%
0/5
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 8
|
60.0%
3/5 • Number of events 3
|
38.5%
5/13 • Number of events 9
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 2
|
23.1%
3/13 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, Nose
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Inf unknown ANC-Ungual (Nails)
|
0.00%
0/3
|
40.0%
2/5 • Number of events 4
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3
|
40.0%
2/5 • Number of events 6
|
30.8%
4/13 • Number of events 27
|
|
Gastrointestinal disorders
Mucositis-Oral
|
33.3%
1/3 • Number of events 1
|
40.0%
2/5 • Number of events 2
|
30.8%
4/13 • Number of events 8
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 2
|
0.00%
0/5
|
53.8%
7/13 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3
|
0.00%
0/5
|
15.4%
2/13 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3
|
20.0%
1/5 • Number of events 5
|
15.4%
2/13 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/3
|
60.0%
3/5 • Number of events 15
|
84.6%
11/13 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Rash acne/acneiform
|
100.0%
3/3 • Number of events 3
|
20.0%
1/5 • Number of events 3
|
0.00%
0/13
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
0.00%
0/5
|
30.8%
4/13 • Number of events 4
|
Additional Information
Dr. Gregory J. Riely
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4199
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place