Dasatinib and Erlotinib in Non-Small Cell Lung Cancer (NSCLC)
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|ClinicalTrials.gov Identifier: NCT00826449|
Recruitment Status : Completed
First Posted : January 22, 2009
Results First Posted : October 21, 2015
Last Update Posted : June 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Non-Small Cell Lung Cancer||Drug: Dasatinib Drug: Erlotinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I-II Study of Dasatinib and Erlotinib in Non-Small Cell Lung Cancer|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Experimental: Phase I
Dasatinib + Erlotinib
Starting dose of 70 mg by mouth daily for 21 day cycle.
150 mg by mouth daily every 21 day cycle.
- Phase I: Maximum Tolerable Dose (MTD) of Dasatinib Given With Erlotinib Hydrochloride [ Time Frame: Baseline and at Day 21 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|