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Tracking Information | |||||||||
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First Received Date † | March 5, 2007 | ||||||||
Last Updated Date | January 30, 2009 | ||||||||
Start Date † | March 2007 | ||||||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00444015 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||||||
Brief Title † | Phase I Dasatinib/Erlotinib in Recurrent NSCLC | ||||||||
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) | ||||||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | Phase I | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
Condition † | Non-Small-Cell Lung Carcinoma | ||||||||
Intervention † | Drug: Erlotinib in combination with Dasatinib | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Enrollment † | 20 | ||||||||
Estimated Completion Date | November 2009 | ||||||||
Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00444015 | ||||||||
Responsible Party | Eric Haura, M.D., H. Lee Moffitt Cancer Center & Research Institute | ||||||||
Secondary IDs †† | BMS Protocol Number: CA180080, 105285b | ||||||||
Study Sponsor † | H. Lee Moffitt Cancer Center and Research Institute | ||||||||
Collaborators †† | Bristol-Myers Squibb | ||||||||
Investigators † |
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Information Provided By | H. Lee Moffitt Cancer Center and Research Institute | ||||||||
Verification Date | January 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |