Non-Small-Cell Lung Carcinoma Clinical Trial
Official title:
Phase I Trial Evaluating the Epidermal Growth Factor Receptor Inhibitor Erlotinib in Combination With the SRC Kinase Inhibitor Dasatinib for Patients With Recurrent Non-small Cell Lung Cancer (NSCLC)
This is a single site phase I dose escalation trial of the epidermal growth factor receptor inhibitor Erlotinib with the SRC tyrosine kinase inhibitor Dasatinib in patients with previously treated advanced stage (Stage IIIB/IV disease) Non-Small Cell Lung Cancer (NSCLC). The treatment regimen consists of Erlotinib tablets starting Day 1 and Dasatinib tablets starting Day 9 for a 28-day cycle. If there are no Dose Limiting Toxicities (DLTs), dose escalation continues. The recommended phase II dose for this combined treatment will be defined and patients will be treated at the recommended phase II dose to confirm tolerability.
This is a single site Phase I dose escalation trial of the epidermal growth factor receptor
inhibitor Erlotinib with the SRC tyrosine kinase inhibitor Dasatinib in patients with
previously treated advanced stage (Stage IIIB/IV disease) Non-Small Cell Lung Cancer
(NSCLC). The screening evaluation will consist of a medical history including
dates/description of your initial NSCLC diagnosis and documentation of any previous
treatment. There will also be a physical examination including vital signs, height, weight,
Eastern Cooperative Oncology Group (ECOG)performance status, blood draws for Complete Blood
Count (CBC) and Complete Metabolic Panel (CMP) tests, neurological examination, a pregnancy
test for female patients of childbearing potential, and (if applicable) any observable tumor
measurements all within 14 days before study enrollment. A screening Electrocardiogram (EKG)
as well as clinical testing to evaluate all known sites of malignant lesions, including
Computed Tomography (CTs) of the chest and upper abdomen, the adrenal glands; ultrasound; or
radionuclide scans of the bones; and/or other radiographic studies should be performed
within 30 days prior to enrollment.
The treatment regimen consists of Erlotinib tablets starting Day 1 and Dasatinib tablets
starting Day 9 for a 28-day cycle. If there are no DLTs, dose escalation continues. Patients
continuing on therapy past two cycles will be seen by the treating physician every 4 weeks
and will have complete History and Physical (H&P), CBC, and CMP. Tumor measurement and
response assessment will occur every 6-8 weeks. Dasatinib and Erlotinib will be continued
until progression of disease, unacceptable toxicity, or patient request.
The recommended phase II dose for this combined treatment will be defined and patients will
be treated at the recommended phase II dose to confirm tolerability.
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