A Study of Dasatinib With Concurrent Chemoradiation for Stage III Non-Small Cell Lung Cancer (NSCLC)

Stopped early · Phase 1

Conditions studied: Non-Small Cell Lung Cancer

In brief

The purpose of this study is to evaluate if a maximum dose of 100 mg of dasatinib with concurrent chemoradiation can be tolerated in patients with chemotherapy naive stage III NSCLC in separate cohorts of locally advanced and potentially resectable disease.

Key facts

Study ID

NCT00787852

Run by

Brown University

People needed

11

Starts

2009-03-01

Expected to finish

2011-12-01

Last updated by the study team

2014-07-30

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer; excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy, [according to AJCC Staging, 6th edition; see Appendix G] within 4 weeks of registration.
• No prior chemotherapy or radiation for lung cancer. No prior radiation for any malignancy within the radiation field.
• Patients may be potentially resectable or unresectable.
• Stage III A or B disease, including no distant metastases- based on following diagnostic workup:
• History/physical examination prior to registration.
• CT Scan of the chest or Pet Scan within 28 days of study entry.
• CT Scan of abdomen or MRI of abdomen or Pet Scan within 28 days of study entry.
• An MRI of the brain or Head CT Scan with contrast within 28 days of study entry.
• Total body PET scan within 6 weeks of study entry is highly recommended and required for operable patients. If a PET scan is performed then a bone scan is not required.
• A bone scan should be performed within 6 weeks of study entry. A bone scan is not needed if a PET scan is performed.
• Mediastinoscopies are highly recommended. Mediastinoscopy is required for all patients not undergoing PET scans and for those who are operable.
• Patients must have measurable or evaluable disease.
• Patients with post-obstructive pneumonia are eligible.
• Patients must be at least 3 weeks from prior thoracotomy (if performed)
• ECOG Performance Status 0-1. Age > 18.
• Post-op predicted FEV1 > 40% to be eligible for surgical resection.
• CBC/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:
• Absolute neutrophil count (ANC) > 1,500 cells/ul.
• Platelets > 100,000 cells/ul.
• Hemoglobin > 9.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > g/dl is acceptable.)
• PT, PTT all Grade 0-1
• Serum creatinine < 1.5 x ULN
• Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN)
• AST and ALT < 2.5 x the ULN
• Serum Na, K+, Mg2+, Phosphate in normal range (LLN)

You may not qualify if…

• Supraclavicular disease
• Pleural or pericardial effusion of any grade
• No prior malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 3 years
• Severe, active co-morbidity, defined as follows:
• Cardiac Symptoms; any of the following should be considered for exclusion:
• Uncontrolled angina, congestive heart failure or MI within (6 months)
• Diagnosed congenital long QT syndrome
• Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
• Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)
• Subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
• Protocol-specific requirements may also exclude immuno-compromised patients
• History of significant bleeding disorder unrelated to cancer, including:
• Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease).
• Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).
• Ongoing or recent (< 3 months) significant gastrointestinal bleeding
• Concomitant Medications, any of the following should be considered for exclusion:
• Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib):
• quinidine, procainamide, disopyramide
• amiodarone, sotalol, ibutilide, dofetilide
• erythromycin, clarithromycin
• chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
• Women who:are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or have a positive pregnancy test at baseline, or are pregnant or breastfeeding

Where it is running

• Lifespan Hospitals — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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