Dasatinib and Erlotinib in Non-Small Cell Lung Cancer (NSCLC)
The goal of the Phase I portion of this study is to find the highest tolerable dose of the combination of dasatinib and erlotinib hydrochloride that can be given to patients with advanced solid tumors.
The goal of the Phase II portion of this study is to learn if this combination is effective when given to patients with non-small cell lung cancer.
The safety of this combination will be studied in both phases.
Non-Small Cell Lung Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I-II Study of Dasatinib and Erlotinib in Non-Small Cell Lung Cancer|
- Phase I: Maximum Tolerable Dose of dasatinib and erlotinib hydrochloride [ Time Frame: Baseline and at Day 21 ] [ Designated as safety issue: Yes ]
- Phase II: Progression-free survival (PFS) Rate [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: Phase I
Dasatinib + Erlotinib
Starting dose of 70 mg by mouth daily for 21 day cycle.
Other Names:Drug: Erlotinib
150 mg by mouth daily every 21 day cycle.
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Faye M. Johnson, MD, PhD, BS||UT MD Anderson Cancer Center|