Clinical trial NCT00470054 (phase 2, status: completed)
Conditions: extensive stage small cell lung cancer, limited stage small cell lung cancer, recurrent small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: dasatinib
SMILES: CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1
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