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

NCT00125372 | Completed Results DMC

• 1 other identifier: D-0453
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-small-cell Lung

Keywords

tarceva; targretin; non-small cell lung cancer; carcinoma, non-small cell lung cancer; nsclc

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Change in Expression Level of EGFR.

  Baseline and 9 days

• Number of Participants With Change in Expression Level of Cyclin D1

  Baseline and 9 days

• Number of Participants With Change in Expression Level of Phosphorylated EGFR (pEGFR)

  Baseline and 9 days

Secondary Outcomes (2)

• Tumor Tissue Concentrations of Erlotinib and Bexarotene and Correlation With Plasma Levels

  At 9 days

• Number of Participants With EGFR Mutations and Correlation of EGFR Mutations With Response

  Baseline and 9 days

Study Arms (1)

Erlotinib and Bexarotene

EXPERIMENTAL

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)

Interventions

erlotinib (Tarceva) and bexarotene (Targretin) DRUG

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

Also known as: Tarceva, Targretin

Erlotinib and Bexarotene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resectable stage I or II non-small-cell lung cancer
• Prior tissue biopsy (not cytology) available for research analysis
• Adequate hepatic and renal function

You may not qualify if:

• Prior chemotherapy or radiotherapy

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Ligand Pharmaceuticals: collaborator
• Genentech, Inc.: collaborator

Study Sites (1)

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma

Interventions

Erlotinib Hydrochloride; Bexarotene

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Konstantin Dragnev, MD
• Organization: Dartmouth-Hitchcock Medical Center

Konstantin.H.Dragnev@hitchcock.org

603-650-6344

Study Officials

• Konstantin H Dragnev, MD

  Norris Cotton Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 29, 2005
• First Posted: August 1, 2005
• Study Start: December 1, 2005
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 8, 2019
• Results First Posted: November 13, 2018

Record last verified: 2018-12

Locations

US (1)