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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Bristol-Myers Squibb |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00444015 |
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 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.
Condition | Intervention | Phase |
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Non-Small-Cell Lung Carcinoma |
Drug: Erlotinib in combination with Dasatinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 20 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: Erlotinib in combination with Dasatinib
6 Cycles @ 28 Days
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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, ECOG performance status, blood draws for CBC and 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 EKG as well as clinical testing to evaluate all known sites of malignant lesions, including 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 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow reserve and organ function as follows:
Exclusion Criteria:
History of significant bleeding disorder unrelated to cancer, including:
Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes including:
Contact: Eric B. Haura, MD | 813-745-6826 | ERIC.HAURA@MOFFITT.ORG |
Contact: Leticia Tetteh, RN | 813-745-4617 | leticia.tetteh@moffitt.org |
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Leticia Tetteh 813-745-4617 leticia.tetteh@moffitt.org | |
Sub-Investigator: Scott Antonia, MD | |
Sub-Investigator: Gerold Bepler, M.D. PhD | |
Sub-Investigator: Alberto Chiappori, MD | |
Sub-Investigator: George Simon, MD | |
Sub-Investigator: Tawee Tanvetyanon, MD | |
Sub-Investigator: Charles Williams, MD | |
Sub-Investigator: Richard Lush, PhD | |
H. Lee Moffitt Cancer Center & Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Jill McHale, RN 813-745-8384 jill.mchale@moffitt.org |
Principal Investigator: | Eric B. Haura, MD | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center & Research Institute ( Eric Haura, M.D. ) |
Study ID Numbers: | MCC-14984, BMS Protocol Number: CA180080, 105285b |
Study First Received: | March 5, 2007 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00444015 History of Changes |
Health Authority: | United States: Institutional Review Board |
Erlotinib Dasatinib Epidermal growth factor receptor (EGFR) Tyrosine kinase |
NSCLC Pharmacokinetics (PK) Lung |
Thoracic Neoplasms Erlotinib Protein Kinase Inhibitors Recurrence Carcinoma Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Dasatinib Non-small Cell Lung Cancer Mitogens Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Erlotinib Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Dasatinib Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |