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Phase II Study of Dasatinib in Non Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

Phase II Study of Dasatinib in Non Small Cell Lung Cancer


I. Determine the progression-free survival at 12 weeks in patients with stage IIIB or IV or
recurrent non-small cell lung cancer treated with dasatinib.


I. Determine the rate of response in patients treated with this drug. II. Examine the
relationship between clinical response to this drug and epidermal growth factor receptor
(EGFR) mutational status, EGFR copy number, and pSrc expression levels in pre-treatment
tumor biopsies.

III. Determine the toxicity of this drug.


Patients received oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days
in the absence of disease progression or unacceptable toxicity.

Previously obtained paraffin-embedded tumor tissue samples are analyzed by polymerase chain
reaction and fluorescent in situ hybridization (FISH) for epidermal growth factor receptor
and by immunohistochemistry for pSrc expression.

Inclusion Criteria:

- Platelet count >= 100,000/mm^3

- Histologically or cytologically confirmed non-small cell lung cancer meeting 1 of the
following criteria:

- Stage IV disease

- Stage IIIB disease with pleural effusion

- Recurrent disease after surgery or radiotherapy

- Measurable disease, defined as >= 1 lesion that can be accurately measured in at
least 1 dimension (longest diameter to be recorded) >= 20 mm by conventional
techniques OR >= 10 mm by spiral CT scan

- Previously treated brain metastasis allowed, provided there is no bleeding, no
midline shift, no need for steroids or anti-convulsants, and no symptoms

- Must agree to obtain residual tumor tissue available from the existing diagnostic
biopsy tumor tissue

- ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%

- Life expectancy > 12 weeks

- WBC >= 3,000/mm^3

- Absolute neutrophil count >= 1,500/mm^3

- Bilirubin =< 1.5 times upper limit of normal (ULN)

- AST and ALT =< 2.5 times ULN

- Creatinine =< 3 times ULN OR Creatinine clearance >= 60 mL/min

- No uncontrolled congestive heart failure or potentially life-threatening arrhythmia

- No angina at rest

- No neuropathy >= grade 2

- No chronic diarrhea or history of inflammatory bowel disease

- No history of pulmonary fibrosis (other than in an irradiated field)

- No other concurrent serious medical illness

- O2 saturation > 92% on room air

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No history of allergic reactions to compounds of similar chemical or biological
composition to dasatinib

- No QTc prolongation (i.e., QTC >= 480 msec) or other significant ECG abnormalities
that could lead to adverse effects if the QTc interval were prolonged

- No medical condition that impairs the ability to swallow, retain, or absorb dasatinib
including, but not limited to, any of the following:

- Gastrointestinal tract disease resulting in an inability to take oral
medication, requirement for IV alimentation, prior surgical procedures affecting
absorption, active peptic ulcer disease

- No myocardial infarction or ventricular tachyarrhythmia within the past 6 months

- LVEF normal

- No major conduction abnormality (unless cardiac pacemaker is present)

- No ongoing or active infection

- No history of significant bleeding disorder (congenital [von Willebrand's disease] or
acquired [antifactor VIII antibodies])

- No psychiatric illness or social situation that would preclude study compliance

- No prior chemotherapy or biologic therapy for recurrent or metastatic non-small cell
lung cancer

- Adjuvant cytotoxic chemotherapy after surgical resection or chemotherapy with
radiation for locally advanced disease (curative intent) allowed provided disease
recurrence >= 3 months after completion of last chemotherapy dose

- Measurable disease must be outside the radiotherapy port OR clearly growing inside
the port

- No prior radiotherapy to >= 25% of the marrow-containing skeleton

- At least 7 days since prior and no concurrent medications that are inhibitors or
inducers of CYP3A4

- At least 7 days since prior and no concurrent agents with proarrhythmic potential

- No other concurrent investigational agents

- No other concurrent anticancer agents or therapies

- No concurrent antiretroviral therapy for HIV-positive patients

- No concurrent systemic antacids (H2 receptor antagonists and proton pump inhibitors)

- Locally acting antacids allowed except for 2 hours before and after dasatinib

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

We will summarize the performance of the experimental therapy by computing the proportion of patients alive and progression free at 12 weeks and corresponding 95% posterior credible interval, both for the entire set of patients and separately by mutation status.

Outcome Time Frame:

Time from start of treatment to time of progression or death, assessed at 12 weeks

Safety Issue:


Principal Investigator

Faye Johnson

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



M D Anderson Cancer Center Houston, Texas  77030