Phase I Dasatinib/Erlotinib in Recurrent Non-small Cell Lung Cancer (NSCLC)
|Non-Small-Cell Lung Carcinoma||Drug: Erlotinib in combination with Dasatinib||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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)|
- Number of Serious Adverse Events (SAEs) Reported [ Time Frame: 3 months per patient ]Determine the safety and tolerability of erlotinib in combination with dasatinib in patients with advanced NSCLC
- Determine Maximum Tolerated Dose (MTD) [ Time Frame: 3 months per patient ]Determine the MTD of erlotinib in combination with dasatinib and the phase II dose
- Pharmacokinetics (PK) [ Time Frame: 3 months per patient ]Characterize the pharmacokinetics of the erlotinib/dasatinib combination
- Changes in Serum Vascular Endothelial Growth Factor (VEGF) and Interleukin(IL)-8 Pre-treatment and Post-treatment [ Time Frame: 3 months per patient ]Assess serum angiogenic markers as pharmacodynamic markers of treatment
- Number of Participants With Complete Response (CR) and Partial Response (PR) [ Time Frame: 3 to 6 months ]Estimate the objective response rate (CR and partial response PR). Partial Response is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Complete Response is defined as disappearance of all target lesions.
- Number of Participants With Progression Free Survival (PFS) [ Time Frame: 6 months ]Estimate the 6-month progression free survival rate
|Study Start Date:||March 2007|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
|Experimental: Dose Escalation||
Drug: Erlotinib in combination with Dasatinib
6 Cycles @ 28 Days
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444015
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Eric B. Haura, MD||H. Lee Moffitt Cancer Center and Research Institute|