Trial Outcomes & Findings for Study of Tarceva and Targretin in Stage I-II Lung Cancer (NCT NCT00125372)
NCT ID: NCT00125372
Last Updated: 2019-01-08
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Baseline and 9 days
Results posted on
2019-01-08
Participant Flow
Participant milestones
| Measure |
Erlotinib and Bexarotene
Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.
erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Erlotinib and Bexarotene
n=10 Participants
Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.
erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
|
Smoking status
Current
|
3 Participants
n=10 Participants
|
|
Smoking status
Never
|
1 Participants
n=10 Participants
|
|
Smoking status
Former
|
6 Participants
n=10 Participants
|
|
Histology
Sqamous Cell carcinoma
|
1 Participants
n=10 Participants
|
|
Histology
Adenocarcinoma
|
6 Participants
n=10 Participants
|
|
Histology
Adenosquamous carcinoma
|
1 Participants
n=10 Participants
|
|
Histology
Bronchioloalveolar carcinoma
|
1 Participants
n=10 Participants
|
|
Histology
Basaloid carcinoma
|
1 Participants
n=10 Participants
|
|
EGFR Status
Wild Type
|
8 Participants
n=10 Participants
|
|
EGFR Status
Mutant
|
1 Participants
n=10 Participants
|
|
EGFR Status
Not assessed
|
1 Participants
n=10 Participants
|
|
KRAS Status
Wild type
|
4 Participants
n=10 Participants
|
|
KRAS Status
Mutant
|
5 Participants
n=10 Participants
|
|
KRAS Status
Not assessed
|
1 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and 9 daysOutcome measures
| Measure |
Erlotinib and Bexarotene
n=10 Participants
Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.
erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
|
|---|---|
|
Number of Participants With Change in Expression Level of EGFR.
Reduction in EGFR expression
|
3 Participants
|
|
Number of Participants With Change in Expression Level of EGFR.
No change
|
7 Participants
|
PRIMARY outcome
Timeframe: Baseline and 9 daysOutcome measures
| Measure |
Erlotinib and Bexarotene
n=10 Participants
Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.
erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
|
|---|---|
|
Number of Participants With Change in Expression Level of Cyclin D1
Reduction in Cyclin D1 expression
|
6 Participants
|
|
Number of Participants With Change in Expression Level of Cyclin D1
No change
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 9 daysOutcome measures
| Measure |
Erlotinib and Bexarotene
n=10 Participants
Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.
erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
|
|---|---|
|
Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR)
Reduction in pEGFR expression
|
6 Participants
|
|
Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR)
No change
|
4 Participants
|
SECONDARY outcome
Timeframe: At 9 daysPopulation: The testing necessary to determine the correlation documented in this outcome was not performed due to budget constraints.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 9 daysPopulation: The numbers analyzed are represented in the rows by EGFR status at baseline. Eight participants had wild-type EGFR at baseline, one had a mutation at Exon 21, and one participant's EGFR status was not assessed at baseline. The total of all rows matches the overall number analyzed; 10.
Outcome measures
| Measure |
Erlotinib and Bexarotene
n=10 Participants
Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.
erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
|
|---|---|
|
Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response
Wild-type EGFR · Therapeutic Response
|
4 Participants
|
|
Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response
Wild-type EGFR · No Therepeutic Response
|
4 Participants
|
|
Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response
EGFR Mutation at Exon 21 · Therapeutic Response
|
1 Participants
|
|
Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response
EGFR Mutation at Exon 21 · No Therepeutic Response
|
0 Participants
|
|
Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response
EGFR not assessed at baseline · Therapeutic Response
|
0 Participants
|
|
Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response
EGFR not assessed at baseline · No Therepeutic Response
|
1 Participants
|
Adverse Events
Erlotinib and Bexarotene
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Konstantin Dragnev, MD
Dartmouth-Hitchcock Medical Center
Phone: 603-650-6344
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place