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NCT Number: NCT00125372

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

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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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Tarceva, Targretin

Primary outcomes

  1. Number of Participants With Change in Expression Level of EGFR.

    Time frame: Baseline and 9 days

  2. Number of Participants With Change in Expression Level of Cyclin D1

    Time frame: Baseline and 9 days

  3. Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR)

    Time frame: Baseline and 9 days

Secondary outcomes

  1. Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels

    Time frame: At 9 days

  2. Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response

    Time frame: Baseline and 9 days

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Genentech, Inc.
  • Ligand Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Aug 1, 2005
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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