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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2010-08-31

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.

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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.

Conditions

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Carcinoma, Non-small-cell Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Erlotinib and Bexarotene

Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.

Group Type EXPERIMENTAL

erlotinib (Tarceva) and bexarotene (Targretin)

Intervention Type DRUG

Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Tarceva Targretin

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