- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00125372
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
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Norris Cotton Cancer Center
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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.
|
Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
Other Names:
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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
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Baseline and 9 days
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Number of Participants With Change in Expression Level of Cyclin D1
Time Frame: Baseline and 9 days
|
Baseline and 9 days
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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.
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
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
- Bexarotene
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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