Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer
Condition: Extensive Stage Small Cell Lung Cancer; Limited Stage Small Cell Lung Cancer; Recurrent Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: dasatinib
Intervention description: Given PO
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well dasatinib works in treating patients with relapse
      small cell lung cancer. Dasatinib may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed small cell lung cancer (SCLC) (limited or
             extensive stage disease)

          -  Progressive or recurrent disease after an initial response to first-line treatment
             with a platinum-based chemotherapy with or without concurrent definitive radiotherapy
             to the chest (chemotherapy must have been completed at least 90 days prior to
             documentation of relapse)

          -  Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by
             conventional techniques OR >= 10 mm by spiral CT scan

          -  Lesions that are not considered measurable include the following:

               -  Bone lesions

               -  Leptomeningeal disease

               -  Ascites

               -  Pleural or pericardial effusion

               -  Abdominal masses that are not confirmed and followed by imaging techniques

               -  Cystic lesions

               -  Tumor lesions situated in a previously irradiated area, unless progression after
                  radiotherapy is documented in these lesions

          -  No known brain metastases (previously treated brain metastases allowed provided they
             are neurologically stable for >= 4 weeks)

          -  ECOG performance status 0-1

          -  Platelet count >= 100,000/mm^3

          -  Bilirubin =< 1.5 times upper limit of normal (ULN)

          -  Creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min

          -  AST =< 2.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  No significant cardiac disease, including any of the following:

               -  New York Heart Association class III-IV heart disease

               -  Myocardial infarction or ventricular tachyarrhythmia within the past 6 months

               -  Prolonged QTc > 480 msec (Fridericia correction)

               -  Major conduction abnormality (unless a cardiac pacemaker is present)

          -  No more than 1 prior chemotherapy regimen

          -  No prior dasatinib or compounds of similar chemical composition or similar biologic
             therapeutic activity including, but not limited to, any inhibitors of SRC, BCR-ABL,
             c-KIT, EPHA2, or PDGFRB kinases

          -  At least 2 weeks since prior definitive or palliative radiotherapy (prior radiotherapy
             allowed in the context of combined modality treatment with curative intent for limited
             stage disease; prophylactic cranial radiotherapy; or palliative radiotherapy initially
             or at relapse)

          -  At least 2 weeks since prior surgery and recovered

          -  At least 1 week since prior and no concurrent agents with proarrhythmic potential

          -  At least 1 week since prior and no concurrent CYP3A4 inhibitors or inducers

          -  At least 1 week since prior and no concurrent grapefruit concentrate

          -  No concurrent palliative radiotherapy

          -  No concurrent hormones or other chemotherapeutic agents, except steroids for adrenal
             failure, hormones for noncancer-related conditions (e.g., insulin for diabetes), or
             intermittent dexamethasone as an antiemetic

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent chemotherapeutic or investigational agents

          -  Fertile patients must use effective contraception during and for >= 6 weeks after
             completion of study therapy