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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ligand Pharmaceuticals
Genentech
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00125372
First received: July 29, 2005
Last updated: January 8, 2013
Last verified: January 2013
History of Changes

July 29, 2005
January 8, 2013
December 2005
May 2013   (final data collection date for primary outcome measure)
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 ]
pre and post study analysis of cyclin D1, EGFR, phospho-EGFR, and Ki-67.
Complete list of historical versions of study NCT00125372 on ClinicalTrials.gov Archive Site
  • 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 ]
  • tumor tissue concentrations of erlotinib and bexarotene and correlation with plasma levels.
  • mutational analysis of EGFR and its correlation with response.
Not Provided
Not Provided
 
Study of Tarceva and Targretin in Stage I-II Lung Cancer
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.

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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-small-cell Lung
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
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.
Intervention: Drug: erlotinib (Tarceva) and bexarotene (Targretin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
Not Provided
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00125372
D-0453
Yes
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
  • Ligand Pharmaceuticals
  • Genentech
Principal Investigator: Konstantin H Dragnev, MD Norris Cotton Cancer Center
Dartmouth-Hitchcock Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP