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

Primary Purpose

Carcinoma, Non-small-cell Lung

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
erlotinib (Tarceva) and bexarotene (Targretin)
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-small-cell Lung focused on measuring tarceva, targretin, non-small cell lung cancer, carcinoma, non-small cell lung cancer, nsclc

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Norris Cotton Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erlotinib and Bexarotene

Arm Description

Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.

Outcomes

Primary Outcome Measures

Number of Participants With Change in Expression Level of EGFR.
Number of Participants With Change in Expression Level of Cyclin D1
Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR)

Secondary Outcome Measures

Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels
Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response

Full Information

First Posted
July 29, 2005
Last Updated
December 14, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Ligand Pharmaceuticals, Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00125372
Brief Title
Study of Tarceva and Targretin in Stage I-II Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Ligand Pharmaceuticals, Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-small-cell Lung
Keywords
tarceva, targretin, non-small cell lung cancer, carcinoma, non-small cell lung cancer, nsclc

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erlotinib and Bexarotene
Arm Type
Experimental
Arm Description
Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.
Intervention Type
Drug
Intervention Name(s)
erlotinib (Tarceva) and bexarotene (Targretin)
Other Intervention Name(s)
Tarceva, Targretin
Intervention Description
Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
Primary Outcome Measure Information:
Title
Number of Participants With Change in Expression Level of EGFR.
Time Frame
Baseline and 9 days
Title
Number of Participants With Change in Expression Level of Cyclin D1
Time Frame
Baseline and 9 days
Title
Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR)
Time Frame
Baseline and 9 days
Secondary Outcome Measure Information:
Title
Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels
Time Frame
At 9 days
Title
Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response
Time Frame
Baseline and 9 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantin H Dragnev, MD
Organizational Affiliation
Norris Cotton Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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