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

Not Applicable

Completed

• Conditions: Carcinoma, Non-small-cell Lung
• Interventions: Drug: erlotinib (Tarceva) and bexarotene (Targretin)

• Registration Number: NCT00125372
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Study Timeline

• Study First Submitted: 2005-07-29
• Study First Submitted QC: 2005-07-29
• Study First Posted: 2005-08-01
• Study Start: 2005-12
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2018-08-23
• Results First Submitted QC: 2018-10-08
• Results First Posted: 2018-11-13
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-14
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erlotinib and Bexarotene	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Norris Cotton Cancer Center; 🇺🇸 Lebanon, New Hampshire, United States