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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Bristol-Myers Squibb OSI Pharmaceuticals |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00826449 |
Primary Objectives:
Secondary Objectives:
A. To explore the relationship between clinical response to the combination of dasatinib and erlotinib and epidermal growth factor receptor (EGFR) mutational status, EGFR gene copy number, RAS mutations and expression of pSrc, pEGFR, ErbB2, ErbB3, E-cadherin, and vimentin in pre-treatment tumor biopsies. B. To determine if there is a correlation between drug exposure, clinical response and changes in plasma levels of IL-8, bFGF, PDGF, soluble VEGFR-2, VEGF, or TNF-alpha during treatment with erlotinib and dasatinib.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer Non-Small Cell Lung Cancer |
Drug: Dasatinib Drug: Erlotinib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I-II Study of Dasatinib and Erlotinib in Non-Small Cell Lung Cancer |
Estimated Enrollment: | 59 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Phase I: Experimental
Dasatinib + Erlotinib
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Drug: Dasatinib
Starting dose of 70 mg by mouth daily for 21 day cycle.
Drug: Erlotinib
150 mg by mouth daily every 21 day cycle.
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The Study Drugs:
Screening Tests:
Before you can start treatment on this study, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
Study Groups:
If you are found to be eligible to participate in this study, you will be assigned to a study group based on when you joined this study. Up to 6 groups of 3-6 participants each will be enrolled in the Phase I portion of the study, and up to 35 participants will be enrolled in Phase II.
If you are enrolled in the Phase I portion, the dose of dasatinib you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of dasatinib. Each new group will receive a higher dose of dasatinib than the group before it, if no intolerable side effects were seen. If intolerable side effects are seen, the next group of participants may receive the same dose level or a lower dose level. This will continue until the highest tolerable dose of dasatinib is found.
If you are enrolled in the Phase II portion, you will receive highest tolerated dose level of dasatinib that was found in the Phase I portion.
All participants will receive the same dose level of erlotinib hydrochloride. If the doctor thinks it is needed, the dose level may be lowered.
Study Drug Administration:
If you are in Phase I, on Day -3 of Cycle 1 (3 days before your first dose of study drugs), you will take erlotinib hydrochloride by mouth. On Days 1-19 of Cycle 1, you will be take dasatinib and erlotinib hydrochloride by mouth once a day. On Days 20 and 21 of Cycle 1, you will only take dasatinib by mouth once a day. Every day of Cycles 2 and beyond, you will take dasatinib and erlotinib hydrochloride by mouth once a day.
If you are in Phase II, every day you will take dasatinib and erlotinib hydrochloride by mouth once a day.
Each cycle is 21 days.
Erlotinib hydrochloride and dasatinib should be taken together at the same time every day. The tablets must be swallowed whole and may not be broken.
The tablets should be taken with 1 cup (about 8 ounces) of water. Dasatinib and erlotinib hydrochloride should be taken 1 hour before or 2 hours after meals or any other drugs, and should not be taken with grapefruit juice. The entire dose must be taken at 1 time. If you vomit within 30 minutes of swallowing the tablets, the dose may be replaced if the tablets can be seen and counted. If you are currently taking St. John's Wort, you should stopping taking if for at least 5 days before taking dasatinib.
Study Visits:
At Week 1 of Cycle 1, your vital signs and weight will be measured.
At the end of Week 3 of every cycle, the following tests and procedures will be performed:
At the end of Week 3 of Cycles 1 and 3, you will also have an ECG.
At the end of Week 3 of every other cycle (Cycles 2, 4, 6, and so on), you will also have a chest CT scan or a whole body PET/CT (if necessary) to check the status of the disease.
Phase I PK Testing:
If you are in Phase I, you will have blood (about 2 teaspoons each time) drawn for PK testing.
Length of Study:
You may stay on study for as long as you are benefitting. You will be taken off study if you experience intolerable side effects or the disease gets worse.
End-of-Study Visit:
At the end of your study participation, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
If you are taken off study due to unacceptable side effects, you will be called and asked about any side effects until the side effect gets better or becomes stable.
This is an investigational study. Dasatinib is FDA approved and commercially available for the treatment of acute lymphoid and chronic myeloid leukemia.
Erlotinib hydrochloride is FDA approved and commercially available for the treatment of non-small cell lung cancer. The use of this combination in this study is investigational.
Up to 59 patients will take part in this study. All will be enrolled at M. D. Anderson.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Known HIV-positive patients are ineligible because of the potential for pharmacokinetic interactions between dasatinib and antiretroviral therapy.
In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
Pts currently receiving any of the following medications will be excluded: (a) Any concurrent systemic anticancer therapy; (b) Any concurrent investigational agents (c) Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Pts must discontinue such drugs 7 days or more prior to starting dasatinib):i. quinidine, procainamide, disopyramide;ii. amiodarone, sotalol, ibutilide, dofetilide;iii.
erythromycin, clarithromycin;iv. chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
Contact: Faye M. Johnson, MD, PhD, BS | 713-792-6363 |
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Faye M. Johnson, MD, PhD, BS |
Principal Investigator: | Faye M. Johnson, MD, PhD, BS | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Faye M. Johnson, MD, PhD, BS/Assistant Professor ) |
Study ID Numbers: | 2008-0353 |
Study First Received: | January 20, 2009 |
Last Updated: | May 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00826449 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Advanced Solid Tumors Advanced Cancer Non-Small Cell Lung Cancer NSCLC Solid Tumor Malignancy Dasatinib |
BMS-354825 Sprycel® Erlotinib Erlotinib hydrochloride Tarceva OSI-774 |
Erlotinib Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Dasatinib Lung Diseases |
Non-small Cell Lung Cancer Protein Kinase Inhibitors Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
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 |