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 (MTD) of Dasatinib Given With Erlotinib Hydrochloride [ Time Frame: Baseline and at Day 21 ] [ Designated as safety issue: Yes ]MTD defined as the highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). Dose-limiting toxicity (DLT) defined using NCI Common Terminology Common Terminology Criteria for Adverse Events (CTCAE) version 3 as: grade 3 or higher non-hematologic toxicity (excluding initial nausea and vomiting), grade 4 neutropenia, febrile neutropenia, or grade 4 thrombocytopenia. Grade 3-4 nausea and vomiting that cannot be controlled within 2 weeks with anti-emetics considered a DLT.
- Phase II: Number of Participant With Response According to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Patients who have a partial or complete response or stable disease are defined as progression free. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): At least 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase.
- Phase II: Progression-Free Survival (PFS) Rate [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]A modified Thall, Simon, and Estey (1995) design used in the phase II study to monitor the proportion of patients with NSCLC who are alive and progression free (PFS) at twelve weeks after commencing treatment with dasatinib and erlotinib.
|Study Start Date:||February 2009|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00826449
|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|