Trial Outcomes & Findings for Trial Comparing Cetuximab With Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer (NCT NCT00203931)
NCT ID: NCT00203931
Last Updated: 2014-03-31
Results Overview
Progression-free survival will be defined as the time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2014-03-31
Participant Flow
Participant milestones
| Measure |
Cetuximab
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
|
Cetuximab and Pemetrexed
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
|
Overall Study
COMPLETED
|
20
|
23
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Comparing Cetuximab With Pemetrexed/Cetuximab Therapy for Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Cetuximab
n=20 Participants
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
|
Cetuximab and Pemetrexed
n=23 Participants
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
55 years
n=7 Participants
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
23 participants
n=7 Participants
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Includes evaluable patients (those that received at least 3 doses of cetuximab)
Progression-free survival will be defined as the time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first.
Outcome measures
| Measure |
Cetuximab
n=20 Participants
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
|
Cetuximab and Pemetrexed
n=23 Participants
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
|
|---|---|---|
|
Progression-free Survival
|
1.6 months
Interval 0.9 to 1.9
|
2.3 months
Interval 1.6 to 3.1
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: Includes evaluable patients (those that received at least 3 doses of cetuximab), but the total number analyzed is not 43 because 2 patients died or progressed prior to day 22 of cetuximab therapy and thus were excluded from this analysis.
Progression-free survival in this landmark analysis looking at the utility of early rash in predicting progression-free survival will be defined as the time from day 22 of study therapy until progression (documented according to Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first. Patients last known to be alive and progression-free were censored at the date of the last scan without evidence of progression.
Outcome measures
| Measure |
Cetuximab
n=37 Participants
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
|
Cetuximab and Pemetrexed
n=4 Participants
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
|
|---|---|---|
|
Progression-free Survival Based on Rash Development
|
0.9 months
Standard Error 0.1 • Interval 0.9 to 2.0
|
0.9 months
Standard Error 0.5 • Interval 0.03 to
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Includes evaluable patients (those that received at least 3 doses of cetuximab).
Objective response (complete response \[CR\] + partial response \[PR\]) will be evaluated using RECIST criteria. CR is the disappearance of all target lesions. PR requires at least a 30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Cetuximab
n=20 Participants
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
|
Cetuximab and Pemetrexed
n=23 Participants
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
|
|---|---|---|
|
Objective Response Rate
|
0 percentage of participants
Interval 0.0 to 16.8
|
13.0 percentage of participants
Interval 2.8 to 33.6
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Includes evaluable patients (those that received at least 3 doses of cetuximab)
Overall survival will be defined as the time from the start of treatment until death from any cause.
Outcome measures
| Measure |
Cetuximab
n=20 Participants
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
|
Cetuximab and Pemetrexed
n=23 Participants
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
|
|---|---|---|
|
Overall Survival
|
3.5 months
Interval 2.8 to 11.7
|
10.3 months
Interval 7.5 to 16.8
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: Includes evaluable patients (those that received at least 3 doses of cetuximab), but the total number analyzed is not 43 because 10 patients did not have a pre-treatment/baseline serum marker classification and thus were excluded from this analysis.
Progression-free survival in this analysis looking at the association between a serum proteomic biomarker and progression-free survival will be defined as the time from the start of treatment until progression (documented according to Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions) or death from any cause, whichever comes first.
Outcome measures
| Measure |
Cetuximab
n=12 Participants
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
|
Cetuximab and Pemetrexed
n=21 Participants
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
|
|---|---|---|
|
Progression-free Survival Based on Serum Biomarker Status
|
1.57 months
Interval 0.7 to 1.9
|
1.64 months
Interval 1.6 to 3.3
|
Adverse Events
Cetuximab
Serious events: 11 serious events
Other events: 15 other events
Deaths: 0 deaths
Cetuximab and Pemetrexed
Serious events: 7 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cetuximab
n=20 participants at risk
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
|
Cetuximab and Pemetrexed
n=23 participants at risk
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
2/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
4.3%
1/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Eye disorders
Cataract
|
0.00%
0/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
4.3%
1/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Infections and infestations
Sepsis
|
0.00%
0/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
4.3%
1/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
General disorders
Pain
|
10.0%
2/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
4.3%
1/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
General disorders
Fever
|
5.0%
1/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
0.00%
0/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
1/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
0.00%
0/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
4.3%
1/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
4.3%
1/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Nervous system disorders
Vasovagal reaction
|
5.0%
1/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
0.00%
0/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
0.00%
0/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
0.00%
0/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
10.0%
2/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
0.00%
0/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Infections and infestations
Infection
|
10.0%
2/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
8.7%
2/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Investigations
Neutrophil count decreased
|
5.0%
1/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
0.00%
0/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
0.00%
0/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
4.3%
1/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Vascular disorders
Thromboembolic event
|
5.0%
1/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
8.7%
2/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
1/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
0.00%
0/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
Other adverse events
| Measure |
Cetuximab
n=20 participants at risk
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
|
Cetuximab and Pemetrexed
n=23 participants at risk
Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
|
|---|---|---|
|
General disorders
Fatigue
|
25.0%
5/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
0.00%
0/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.0%
1/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
0.00%
0/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
0.00%
0/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
General disorders
Pain
|
5.0%
1/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
0.00%
0/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
2/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
0.00%
0/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
55.0%
11/20 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
73.9%
17/23 • up to 5 years
Serious adverse events of any grade are reported. For all other adverse events, only those grade 3 or higher were collected during the study. Adverse events are reported for the evaluable patients who received at least 3 doses of Cetuximab
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place