A Clinical and Pharmacologic Study of the Combination of Erlotinib and Bexarotene in Resectable Clinical Stage I-II Non-Small Cell Lung Cancer
18 Years
N/A
Both
Carcinoma, Non-small-cell Lung
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 Center | Lebanon, New Hampshire 03756 |
