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

Dartmouth Health

Status: Completed

Conditions: Carcinoma, Non-small-cell Lung

Treatments: Drug: erlotinib (Tarceva) and bexarotene (Targretin)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00125372

D-0453

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Erlotinib and Bexarotene

Experimental group

Description:

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

Treatment:

Drug: erlotinib (Tarceva) and bexarotene (Targretin)