Trial Outcomes & Findings for Erlotinib Hydrochloride Before Surgery in Treating Patients With Stage III Non-Small Cell Lung Cancer (NCT NCT01857271)
NCT ID: NCT01857271
Last Updated: 2020-07-08
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
3 years 9 months
Results posted on
2020-07-08
Participant Flow
The patients were enrolled on 11/7/2013, 5/2014, and 9/24/2014.
The study was difficult to enroll and eventually terminated/closed.
Participant milestones
| Measure |
Treatment (Erlotinib Hydrochloride)
Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo restaging procedures to evaluate for surgery.
Erlotinib Hydrochloride: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Erlotinib Hydrochloride)
Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo restaging procedures to evaluate for surgery.
Erlotinib Hydrochloride: Given PO
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Erlotinib Hydrochloride Before Surgery in Treating Patients With Stage III Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Erlotinib Hydrochloride and Thoracotomy)
n=3 Participants
Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo thoracotomy.
Erlotinib Hydrochloride: Given PO
Therapeutic Conventional Surgery: Undergo thoracotomy
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
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 years 9 monthsPopulation: The study was closely prematurely due to poor accrual. No final analysis was performed due to very low number of subjects.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Erlotinib Hydrochloride and Thoracotomy)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Erlotinib Hydrochloride and Thoracotomy)
n=3 participants at risk
Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo thoracotomy.
Erlotinib Hydrochloride: Given PO
Therapeutic Conventional Surgery: Undergo thoracotomy
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place