Study of Tarceva and Targretin in Stage I-II Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Clinical and Pharmacologic Study of the Combination of Erlotinib and Bexarotene in Resectable Clinical Stage I-II Non-Small Cell Lung Cancer

Conditions
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Carcinoma, Non-small-cell Lung

Intervention / Treatment
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* Drug: erlotinib (Tarceva) and bexarotene (Targretin)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erlotinib and Bexarotene<br>Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy. | Drug: erlotinib (Tarceva) and bexarotene (Targretin)<br>* Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy<br>* Other names: Targretin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tarceva, targretin, non-small cell lung cancer, carcinoma, non-small cell lung cancer, nsclc