Trial Outcomes & Findings for Erlotinib and Cetuximab in Treating Patients With Advanced Solid Tumors With Emphasis on Non-Small Cell Lung Cancer (NCT NCT00408499)
NCT ID: NCT00408499
Last Updated: 2017-05-08
Results Overview
Patients will be followed during cycle 1 for the occurrence of a protocol defined dose limiting toxicity
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
64 participants
Primary outcome timeframe
baseline through cycle 1 of treatment
Results posted on
2017-05-08
Participant Flow
Participant milestones
| Measure |
Dose Level 1
100 mg Erlotinib, 150 mg/m2 Cetuximab
|
Dose Level 2
100 mg Erlotinib, 200 mg/m2 Cetuximab
|
Dose Level 3
100 mg Erlotinib, 250 mg/m2 Cetuximab
|
Dose Level 4
150 mg Erlotinib, 250 mg/m2 Cetuximab
|
Phase II- Dose Expansion
Phase II dose expansion at determined MTD
|
|---|---|---|---|---|---|
|
Phase 1: Dose Levels 1-4
STARTED
|
4
|
7
|
3
|
6
|
0
|
|
Phase 1: Dose Levels 1-4
COMPLETED
|
2
|
5
|
2
|
6
|
0
|
|
Phase 1: Dose Levels 1-4
NOT COMPLETED
|
2
|
2
|
1
|
0
|
0
|
|
Phase II- MTD Expansion
STARTED
|
0
|
0
|
0
|
0
|
44
|
|
Phase II- MTD Expansion
COMPLETED
|
0
|
0
|
0
|
0
|
24
|
|
Phase II- MTD Expansion
NOT COMPLETED
|
0
|
0
|
0
|
0
|
20
|
Reasons for withdrawal
| Measure |
Dose Level 1
100 mg Erlotinib, 150 mg/m2 Cetuximab
|
Dose Level 2
100 mg Erlotinib, 200 mg/m2 Cetuximab
|
Dose Level 3
100 mg Erlotinib, 250 mg/m2 Cetuximab
|
Dose Level 4
150 mg Erlotinib, 250 mg/m2 Cetuximab
|
Phase II- Dose Expansion
Phase II dose expansion at determined MTD
|
|---|---|---|---|---|---|
|
Phase 1: Dose Levels 1-4
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Phase 1: Dose Levels 1-4
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
|
Phase 1: Dose Levels 1-4
Physician Decision
|
1
|
1
|
0
|
0
|
0
|
|
Phase II- MTD Expansion
Adverse Event
|
0
|
0
|
0
|
0
|
9
|
|
Phase II- MTD Expansion
Death
|
0
|
0
|
0
|
0
|
2
|
|
Phase II- MTD Expansion
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
|
Phase II- MTD Expansion
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
5
|
|
Phase II- MTD Expansion
treatment delay
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Erlotinib and Cetuximab in Treating Patients With Advanced Solid Tumors With Emphasis on Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Erlotinib + Cetuximab
n=64 Participants
cetuximab: Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.
erlotinib: Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
|
Age, Continuous
|
62.91 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline through cycle 1 of treatmentPatients will be followed during cycle 1 for the occurrence of a protocol defined dose limiting toxicity
Outcome measures
| Measure |
Dose Level 1
n=4 Participants
100 mg Erlotinib, 150 mg/m2 Cetuximab
|
Dose Level 2
n=7 Participants
100 mg Erlotinib, 200 mg/m2 Cetuximab
|
Dose Level 3
n=3 Participants
100 mg Erlotinib, 250 mg/m2 Cetuximab
|
Dose Level 4
n=6 Participants
150 mg Erlotinib, 250 mg/m2 Cetuximab
|
|---|---|---|---|---|
|
Number of Patients Experiencing a DLT
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Every two cycles from first dose to last dose of study drugsTo determine the efficacy, as measured by objective tumor response rate (RICIST criteria), of daily oral erlotinib and weekly intravenous cetuximab in patients with advanced NSCLC. Best overall response per patient will be reported below.
Outcome measures
| Measure |
Dose Level 1
n=64 Participants
100 mg Erlotinib, 150 mg/m2 Cetuximab
|
Dose Level 2
100 mg Erlotinib, 200 mg/m2 Cetuximab
|
Dose Level 3
100 mg Erlotinib, 250 mg/m2 Cetuximab
|
Dose Level 4
150 mg Erlotinib, 250 mg/m2 Cetuximab
|
|---|---|---|---|---|
|
Number of Patients Correlated With Best Overall Response.
Complete/Partial response
|
2 Participants
|
—
|
—
|
—
|
|
Number of Patients Correlated With Best Overall Response.
Stable Disease
|
19 Participants
|
—
|
—
|
—
|
|
Number of Patients Correlated With Best Overall Response.
Progressive disease
|
22 Participants
|
—
|
—
|
—
|
|
Number of Patients Correlated With Best Overall Response.
Not evaluable
|
21 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Patients will be followed until deathPopulation: 44 patients were enrolled into the Phase II portion of the study
In the Phase II portion of the study, patients will be followed for both disease free progression by capturing disease progression date and for over all survival by capturing death date.
Outcome measures
| Measure |
Dose Level 1
n=44 Participants
100 mg Erlotinib, 150 mg/m2 Cetuximab
|
Dose Level 2
100 mg Erlotinib, 200 mg/m2 Cetuximab
|
Dose Level 3
100 mg Erlotinib, 250 mg/m2 Cetuximab
|
Dose Level 4
150 mg Erlotinib, 250 mg/m2 Cetuximab
|
|---|---|---|---|---|
|
Patient Outcome
Deceased
|
29 Participants
|
—
|
—
|
—
|
|
Patient Outcome
Not followed
|
9 Participants
|
—
|
—
|
—
|
|
Patient Outcome
Withdrew consent
|
4 Participants
|
—
|
—
|
—
|
|
Patient Outcome
Alive when study terminated
|
2 Participants
|
—
|
—
|
—
|
Adverse Events
Erlotinib + Cetuximab
Serious events: 4 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib + Cetuximab
n=64 participants at risk
cetuximab: Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.
erlotinib: Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Cardiac disorders
Thrombosis/thrombus/embolism
|
1.6%
1/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Nervous system disorders
Dizziness
|
1.6%
1/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Gastrointestinal disorders
Bronchospasm
|
1.6%
1/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
Other adverse events
| Measure |
Erlotinib + Cetuximab
n=64 participants at risk
cetuximab: Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.
erlotinib: Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
10.9%
7/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Investigations
Aspartate aminotransferase Increased
|
28.1%
18/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Gastrointestinal disorders
Anorexia
|
10.9%
7/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Investigations
Bilirubin increased
|
20.3%
13/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Skin and subcutaneous tissue disorders
Acneiform rash
|
67.2%
43/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Gastrointestinal disorders
Constipation
|
7.8%
5/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
3/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Investigations
Creatinine Increased
|
7.8%
5/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.7%
3/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Gastrointestinal disorders
Diarrhea
|
39.1%
25/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Nervous system disorders
Dizziness
|
7.8%
5/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Investigations
Alkaline phosphatase increased
|
14.1%
9/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
32.8%
21/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
General disorders
Edema limbs
|
6.2%
4/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
General disorders
Fatigue
|
48.4%
31/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
General disorders
Fever
|
6.2%
4/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Nervous system disorders
Headache
|
9.4%
6/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Gastrointestinal disorders
Heartburn
|
4.7%
3/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
20.3%
13/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.7%
3/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
18.8%
12/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
8/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.2%
11/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
42.2%
27/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.2%
11/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.8%
5/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
8/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
32.8%
21/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Gastrointestinal disorders
Mucositis
|
18.8%
12/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
6.2%
4/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Gastrointestinal disorders
Nausea
|
28.1%
18/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
8/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
29.7%
19/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Skin and subcutaneous tissue disorders
Rash desquamtion
|
15.6%
10/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
|
Gastrointestinal disorders
Vomiting
|
17.2%
11/64 • Adverse event data was collected day 1 of every cycle for enrolled patients. Total time of collection for all patients: 6 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place