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A Clinical and Pharmacologic Study of the Combination of Erlotinib and Bexarotene in Resectable Clinical Stage I-II Non-Small Cell Lung Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-small-cell Lung

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Trial Information

A Clinical and Pharmacologic Study of the Combination of Erlotinib and Bexarotene in Resectable Clinical Stage I-II Non-Small Cell Lung Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pre and post study analysis of cyclin D1, epidermal growth factor receptor (EGFR), phospho-EGFR, and Ki-67

Outcome Time Frame:

Analyses to be performed after accrual goal has been met

Safety Issue:

No

Principal Investigator

Konstantin H Dragnev, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Norris Cotton Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

D-0453

NCT ID:

NCT00125372

Start Date:

December 2005

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • tarceva
  • targretin
  • non-small cell lung cancer
  • carcinoma, non-small cell lung cancer
  • nsclc
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Norris Cotton Cancer CenterLebanon, New Hampshire  03756