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

Sponsors and Collaborators:	Dartmouth-Hitchcock Medical Center Ligand Pharmaceuticals Genentech
Information provided by:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00125372

Purpose

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)

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib Erlotinib hydrochloride Bexarotene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
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

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
mutational analysis of EGFR and its correlation with response [ Time Frame: Analyses to be performed after accrual goal has been met ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	December 2005
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125372

Contacts

Contact: Konstantin H Dragnev, MD	603-650-6344	Konstantin.H.Dragnev@Dartmouth.edu
Contact: Brendan M Slagle, BS	603-653-0590	brendan.m.slagle@dartmouth.edu

Locations

United States, New Hampshire
Norris Cotton Cancer Center	Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New York
Mount Sinai School of Medicine	Withdrawn
New York City, New York, United States, 10029

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Ligand Pharmaceuticals

Genentech

Investigators

Principal Investigator:

Konstantin H Dragnev, MD

Norris Cotton Cancer Center

More Information

Responsible Party:	Dartmouth-Hitchcock Medical Center ( Konstantin H. Dragnev, MD )
Study ID Numbers:	D-0453
Study First Received:	July 29, 2005
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00125372
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dartmouth-Hitchcock Medical Center:

tarceva
targretin
non-small cell lung cancer

carcinoma, non-small cell lung cancer
non-small cell lung cancer
nsclc

Study placed in the following topic categories:

Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Bexarotene

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Anticarcinogenic Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Protective Agents
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009