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

This study has been completed.
Ligand Pharmaceuticals
Genentech, Inc.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center Identifier:
First received: July 29, 2005
Last updated: July 14, 2014
Last verified: July 2014
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.

Condition Intervention
Carcinoma, Non-small-cell Lung
Drug: erlotinib (Tarceva) and bexarotene (Targretin)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical and Pharmacologic Study of the Combination of Erlotinib and Bexarotene in Resectable Clinical Stage I-II Non-Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • pre and post study analysis of cyclin D1, epidermal growth factor receptor (EGFR), phospho-EGFR, and Ki-67 [ Time Frame: Analyses to be performed after accrual goal has been met ]

Secondary Outcome Measures:
  • tumor tissue concentrations of erlotinib and bexarotene and correlation with plasma levels [ Time Frame: Analyses to be performed after accrual goal has been met ]
  • mutational analysis of EGFR and its correlation with response [ Time Frame: Analyses to be performed after accrual goal has been met ]

Enrollment: 15
Study Start Date: December 2005
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib and Bexarotene
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)
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00125372

United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Ligand Pharmaceuticals
Genentech, Inc.
Principal Investigator: Konstantin H Dragnev, MD Norris Cotton Cancer Center
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00125372     History of Changes
Other Study ID Numbers: D-0453
Study First Received: July 29, 2005
Last Updated: July 14, 2014

Keywords provided by Dartmouth-Hitchcock Medical Center:
non-small cell lung cancer
carcinoma, non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs processed this record on April 28, 2017