Dasatinib in Advanced Squamous Cell Lung Cancer
Condition: Squamous Cell Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Dasatinib
Intervention description: 140 mg orally, daily in 28 day cycles
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung cancer; NSCLC; Stage IIIB; Stage IV

Summary:

      Dasatinib is a drug that has been shown to stop some cancer cells from growing. This drug has
      been used in treatment for other types of cancer and information from other research studies
      suggests that dasatinib may help to stop squamous cell lung cancer from growing, especially
      in individuals whose tumor has a mutation in the DDR2 gene.

      Advanced squamous cell lung cancer (SqCC) carries a poor prognosis and new therapeutic
      targets are needed. Several studies have examined dasatinib in NSCLC; these report
      significant toxicities, but also responses in patients found to harbor mutations in DDR2 or
      BRAF.

      An open-label phase II trial with dasatinib was carried out to determine the response rates
      in patients with SqCC who had previously failed standard chemotherapy and to correlate
      responses with patient genotype.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage III/B or IV squamous NSCLC

          -  Measurable disease

          -  Previously offered all standard chemotherapy regimens for advanced squamous cell lung
             cancer

          -  ECOG performance status of 0 or 1

          -  Estimated life expectancy greater than 12 weeks

          -  Normal organ and marrow function

          -  Confirmed availability of archival pathology samples

          -  Agrees to discontinue St. Johns Wort

          -  Able to take medications by mouth

          -  Willing and able to use acceptable method of birth control for the entire study period
             and for at least 4 weeks after the last dose of study drug

        Exclusion Criteria:

          -  Pregnant or breast-feeding

          -  Chemotherapy or radiotherapy within 4 weeks prior to entering study

          -  Receiving any other investigational agents

          -  Known untreated or progressive brain metastases

          -  History of prior treatment with or allergic reactions attributed to compounds of
             similar chemical or biologic composition to dasatinib, nilotinib or imatinib

          -  Taking medications known to be potent CYP3A4 inhibitors

          -  Currently taking H2 inhibitors or proton pump inhibitors

          -  Currently taking drugs or have taken drugs in the past 7 days that are generally
             accepted to have a risk of causing Torsades de Pointes

          -  HIV positive

          -  Clinically uncontrolled hypertension (blood pressure > 160/110)

          -  Previous or concurrent malignancy except adequately treated basal or squamous cell
             skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively,
             and without evidence of recurrence for at least 5 years

          -  Active and uncontrolled clinically significant infection

          -  Chronic gastrointestinal disease

          -  Acquired or congenital bleeding disorder or clinically significant gastrointestinal
             bleeding within 3 months

          -  Supplemental oxygen required for current malignancy

          -  Evidence of symptomatic pleural effusions unless undergoing a therapeutic
             thoracentesis as part of non-study care

          -  Individuals who are prisoners or who are compulsory detained for medical or
             psychiatric reasons

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements

          -  Hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib
             administration