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A Phase I Study of Dasatinib With Concurrent Chemoradiation for Stage III NSCLC Principal Investigator: Howard Safran, MD.

Phase 1
19 Years
Not Enrolling
Non-Small Cell Lung Cancer

Thank you

Trial Information

A Phase I Study of Dasatinib With Concurrent Chemoradiation for Stage III NSCLC Principal Investigator: Howard Safran, MD.

Describe the safety of maintenance dasatinib, 100 mg/day for 2 years, in patients with stage

For patients with potentially resectable disease, to assess the pathologic complete response
following neoadjuvant dasatinib, paclitaxel, carboplatin and 50.4 Gy concurrent radiation.

For patients with locally unresectable disease, to obtain radiographic response data
following dasatinib, paclitaxel, carboplatin and 64.8 Gy radiation.

Inclusion Criteria:

- 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

- 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)

- Women of childbearing potential (WOCBP) must have a negative serum or urine
pregnancy test within 72 hours prior to the start of study drug administration.

- Persons of reproductive potential must agree to use and utilize an adequate method of
contraception throughout treatment and for at least 4 weeks after study drug is
stopped prior to study enrollment, women of childbearing potential must be advised of
the importance of avoiding pregnancy during trial participation and the potential
risk factors for an unintentional pregnancy.

- If you are capable of giving birth to or fathering a child, you must agree to use a
form of birth control (examples of effective birth control are: a condom or a
diaphragm with spermicidal jelly; oral, injectable, or implanted birth control; or
abstinence) that is medically acceptable to your study doctor while taking part in
this research study. This is necessary because the treatment involved in this study
may be significantly teratogenic.

- PFT's within 8 weeks of study entry

- EKG within 6 weeks of study entry

- Ability to take oral medication (dasatinib must be swallowed whole)

- Patient must sign study specific informed consent prior to study entry.

- Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy
(discontinue St. Johns Wort at least 5 days before starting dasatinib)

Exclusion Criteria:

- 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

- 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):

1. quinidine, procainamide, disopyramide

2. amiodarone, sotalol, ibutilide, dofetilide

3. erythromycin, clarithromycin

4. chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide,
cisapride, bepridil, droperidol, methadone, arsenic, chloroquine,
domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin,

- 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

- Any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin.

- Uncontrolled neuropathy grade 2 or greater regardless of cause.

- Patients who are on full dose aspirin, Clopidogrel bisulfate (plavix) or other
GPIIb/IIIa platelet inhibitors are not eligible. Patients must have these agents
stopped within 7 days of initiated treatment. Patients may be on low dose
aspirin (81 mg/day).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Measure of Safety and Tolerability according to CTC version 3.0

Outcome Time Frame:

within 28 days after the last radiation treatment

Safety Issue:


Principal Investigator

Teresa A Kennedy, RN

Investigator Role:

Study Director

Investigator Affiliation:

Brown University Oncology Groip


United States: Food and Drug Administration

Study ID:




Start Date:

May 2009

Completion Date:

December 2011

Related Keywords:

  • Non-Small Cell Lung Cancer
  • dasatinib
  • radiation
  • paclitaxel
  • carboplatin
  • safety addition of dasatinib to chemo RT stage III NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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