Trial Outcomes & Findings for Erlotinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer (NCT NCT00287989)
NCT ID: NCT00287989
Last Updated: 2018-12-06
Results Overview
Percentage of patients who experienced complete or partial response as defined by RECIST
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
86 participants
Primary outcome timeframe
after 6 cycles of chemotherapy
Results posted on
2018-12-06
Participant Flow
Participant milestones
| Measure |
150 PRE
Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
|
1,500 PRE
Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
|
1,500 POST
Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
29
|
|
Overall Study
COMPLETED
|
28
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erlotinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
150 PRE
n=28 Participants
Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
|
1,500 PRE
n=29 Participants
Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
|
1,500 POST
n=29 Participants
Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
|
Age, Continuous
|
68 years
n=99 Participants
|
62 years
n=107 Participants
|
62 years
n=206 Participants
|
64 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
86 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: after 6 cycles of chemotherapyPercentage of patients who experienced complete or partial response as defined by RECIST
Outcome measures
| Measure |
150 PRE
n=26 Participants
Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
|
1,500 PRE
n=29 Participants
Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
|
1,500 POST
n=29 Participants
Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
|
|---|---|---|---|
|
Overall Response Rate
|
18 percentage of participants
Interval 6.0 to 37.0
|
34 percentage of participants
Interval 18.0 to 54.0
|
28 percentage of participants
Interval 13.0 to 47.0
|
SECONDARY outcome
Timeframe: after cycle 6 of chemotherapyMedian number of months until disease progression
Outcome measures
| Measure |
150 PRE
n=28 Participants
Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
|
1,500 PRE
n=29 Participants
Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
|
1,500 POST
n=29 Participants
Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
|
|---|---|---|---|
|
Time to Progression
|
4 months
Interval 3.0 to 5.0
|
4 months
Interval 3.0 to 6.0
|
5 months
Interval 3.0 to 8.0
|
Adverse Events
150 PRE
Serious events: 5 serious events
Other events: 2 other events
Deaths: 0 deaths
1,500 PRE
Serious events: 9 serious events
Other events: 2 other events
Deaths: 0 deaths
1,500 POST
Serious events: 8 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
150 PRE
n=28 participants at risk
Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
|
1,500 PRE
n=29 participants at risk
Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
|
1,500 POST
n=29 participants at risk
Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
17.9%
5/28 • Number of events 5
|
31.0%
9/29 • Number of events 9
|
27.6%
8/29 • Number of events 8
|
Other adverse events
| Measure |
150 PRE
n=28 participants at risk
Erlotinib 150mg on days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200 mg/m2
|
1,500 PRE
n=29 participants at risk
Erlotinib 1500mg on Days 1 and 2 of a 21 day cycle and Carboplatin AUC6 and Paclitaxel 200mg/m2
|
1,500 POST
n=29 participants at risk
Carboplatin AUC6, Paclitaxel 200 mg/m2 followed by Erlotinib 1500mg days 2 and 3.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
2/28 • Number of events 2
|
6.9%
2/29 • Number of events 2
|
6.9%
2/29 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place