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| Name | Class |
|---|---|
| Ligand Pharmaceuticals | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib and Bexarotene | Experimental | Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib (Tarceva) and bexarotene (Targretin) | Drug | Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konstantin H Dragnev, MD | Norris Cotton Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Change in Expression Level of EGFR. | Posted | Count of Participants | Participants | Baseline and 9 days |
|
|
Adverse event data was collected for each patient at the start of study treatment until 4 weeks following surgical resection. The total time of adverse event collection over the course of the study from the first treated subject to the last treated patient's end-of-study visit was 4 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Konstantin Dragnev, MD | Dartmouth-Hitchcock Medical Center | 603-650-6344 | Konstantin.H.Dragnev@hitchcock.org |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D000077610 | Bexarotene |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking status | Count of Participants | Participants |
|
| Histology | Count of Participants | Participants |
|
| EGFR Status | Count of Participants | Participants |
|
| KRAS Status | Count of Participants | Participants |
|
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| Primary | Number of Participants With Change in Expression Level of Cyclin D1 | Posted | Count of Participants | Participants | Baseline and 9 days |
|
|
|
| Primary | Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR) | Posted | Count of Participants | Participants | Baseline and 9 days |
|
|
|
| Secondary | Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels | The testing necessary to determine the correlation documented in this outcome was not performed due to budget constraints. | Posted | At 9 days |
|
|
| Secondary | Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response | 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. | Posted | Count of Participants | Participants | Baseline and 9 days |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| EGFR Mutation at Exon 21 |
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| EGFR not assessed at baseline |
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|