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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00125372
Recruitment Status : Completed
First Posted : August 1, 2005
Last Update Posted : July 15, 2014
Ligand Pharmaceuticals
Genentech, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-small-cell Lung Drug: erlotinib (Tarceva) and bexarotene (Targretin) Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2005
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. tumor tissue concentrations of erlotinib and bexarotene and correlation with plasma levels [ Time Frame: Analyses to be performed after accrual goal has been met ]
  2. mutational analysis of EGFR and its correlation with response [ Time Frame: Analyses to be performed after accrual goal has been met ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00125372     History of Changes
Other Study ID Numbers: D-0453
First Posted: August 1, 2005    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: July 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