Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer

This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer Read More

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