Carcinoma, Non-small-cell Lung
Conditions
Keywords
tarceva, targretin, non-small cell lung cancer, carcinoma, non-small cell lung cancer, nsclc
Brief summary
The purpose of this study is to learn the effects on lung cancer of 2 new drugs, Tarceva and Targretin, given in combination before surgical removal of the tumor. Tarceva is approved by the Food and Drug Administration (FDA) for lung cancer. Targretin is approved for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.
Detailed description
Erlotinib 150mg and bexarotene 400mg/m2 will be administered orally for 7-9 days prior to thoracotomy. Plasma samples will be collected on the day before surgery and along with tissue samples on the day of the thoracotomy. Analyses will be done on the resected specimen and it will be compared to the pre-study diagnostic specimen.
Interventions
DRUGerlotinib (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
Sponsors
Ligand Pharmaceuticals
Genentech, Inc.
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Resectable stage I or II non-small-cell lung cancer * Prior tissue biopsy (not cytology) available for research analysis * Adequate hepatic and renal function
Exclusion criteria
* Prior chemotherapy or radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Change in Expression Level of EGFR. | Baseline and 9 days |
| Number of Participants With Change in Expression Level of Cyclin D1 | Baseline and 9 days |
| Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR) | Baseline and 9 days |
Secondary
| Measure | Time frame |
|---|---|
| Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels | At 9 days |
| Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response | Baseline and 9 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Erlotinib and Bexarotene | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 2 Participants | — |
| Age, Categorical Between 18 and 65 years | 8 Participants | — |
| EGFR Status Mutant | 1 Participants | — |
| EGFR Status Not assessed | 1 Participants | — |
| EGFR Status Wild Type | 8 Participants | — |
| Histology Adenocarcinoma | 6 Participants | — |
| Histology Adenosquamous carcinoma | 1 Participants | — |
| Histology Basaloid carcinoma | 1 Participants | — |
| Histology Bronchioloalveolar carcinoma | 1 Participants | — |
| Histology Sqamous Cell carcinoma | 1 Participants | — |
| KRAS Status Mutant | 5 Participants | — |
| KRAS Status Not assessed | 1 Participants | — |
| KRAS Status Wild type | 4 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
| Smoking status Current | 3 Participants | — |
| Smoking status Former | 6 Participants | — |
| Smoking status Never | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Number of Participants With Change in Expression Level of Cyclin D1
Time frame: Baseline and 9 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Erlotinib and Bexarotene | Number of Participants With Change in Expression Level of Cyclin D1 | Reduction in Cyclin D1 expression | 6 Participants |
| Erlotinib and Bexarotene | Number of Participants With Change in Expression Level of Cyclin D1 | No change | 4 Participants |
Primary
Number of Participants With Change in Expression Level of EGFR.
Time frame: Baseline and 9 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Erlotinib and Bexarotene | Number of Participants With Change in Expression Level of EGFR. | Reduction in EGFR expression | 3 Participants |
| Erlotinib and Bexarotene | Number of Participants With Change in Expression Level of EGFR. | No change | 7 Participants |
Primary
Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR)
Time frame: Baseline and 9 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Erlotinib and Bexarotene | Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR) | Reduction in pEGFR expression | 6 Participants |
| Erlotinib and Bexarotene | Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR) | No change | 4 Participants |
Secondary
Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response
Time frame: Baseline and 9 days
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Erlotinib and Bexarotene | Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response | Wild-type EGFR | Therapeutic Response | 4 Participants |
| Erlotinib and Bexarotene | Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response | Wild-type EGFR | No Therepeutic Response | 4 Participants |
| Erlotinib and Bexarotene | Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response | EGFR Mutation at Exon 21 | Therapeutic Response | 1 Participants |
| Erlotinib and Bexarotene | Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response | EGFR Mutation at Exon 21 | No Therepeutic Response | 0 Participants |
| Erlotinib and Bexarotene | Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response | EGFR not assessed at baseline | Therapeutic Response | 0 Participants |
| Erlotinib and Bexarotene | Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response | EGFR not assessed at baseline | No Therepeutic Response | 1 Participants |
Secondary
Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels
Time frame: At 9 days
Population: The testing necessary to determine the correlation documented in this outcome was not performed due to budget constraints.