Study of Tarceva and Targretin in Stage I-II Lung Cancer
Information source: Dartmouth-Hitchcock Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib (Tarceva) and bexarotene (Targretin) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Dartmouth-Hitchcock Medical Center Official(s) and/or principal investigator(s):
Konstantin H Dragnev, MD, Principal Investigator, Affiliation: Norris Cotton Cancer Center
Overall contact:
Konstantin H Dragnev, MD, Phone: 603-650-6344, Email: Konstantin.H.Dragnev@Dartmouth.edu
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.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: pre and post study analysis of cyclin D1, epidermal growth factor receptor (EGFR), phospho-EGFR, and Ki-67
Secondary outcome: tumor tissue concentrations of erlotinib and bexarotene and correlation with plasma levelsmutational analysis of EGFR and its correlation with response
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Konstantin H Dragnev, MD, Phone: 603-650-6344, Email: Konstantin.H.Dragnev@Dartmouth.edu
Norris Cotton Cancer Center, Lebanon, New Hampshire 03756, United States; Recruiting
Mount Sinai School of Medicine, New York City, New York 10029, United States; Withdrawn
Additional Information
Starting date: December 2005
Last updated: April 29, 2009
|
