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

December 14, 2018 updated by: Konstantin Dragnev, Dartmouth-Hitchcock Medical Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Norris Cotton Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Change in Expression Level of EGFR.
Time Frame: Baseline and 9 days
Baseline and 9 days
Number of Participants With Change in Expression Level of Cyclin D1
Time Frame: Baseline and 9 days
Baseline and 9 days
Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR)
Time Frame: Baseline and 9 days
Baseline and 9 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels
Time Frame: At 9 days
At 9 days
Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response
Time Frame: Baseline and 9 days
Baseline and 9 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Genentech, Inc.
Ligand Pharmaceuticals

Investigators

  • Principal Investigator: Konstantin H Dragnev, MD, Norris Cotton Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

July 29, 2005

First Submitted That Met QC Criteria

July 29, 2005

First Posted (Estimate)

August 1, 2005

Study Record Updates

Last Update Posted (Actual)

January 8, 2019

Last Update Submitted That Met QC Criteria

December 14, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-0453

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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