AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer

Inclusion Criteria:

* Histologically or cytologically confirmed small cell lung cancer

  * No mixed histology
* Extensive stage disease, defined as any of the following:

  * Metastatic disease outside the chest
  * Contralateral supraclavicular nodes or contralateral hilar nodes that cannot be included in a single radiation port
  * Cytologically confirmed malignant pleural effusion

    * Clinically significant effusions (e.g., symptomatic pleural effusion) must be drained prior to treatment
* Previously untreated disease\* OR stable disease, partial response, or complete response ≤ 4 weeks after completion of one course (four 3-week courses) of standard platinum-based chemotherapy
* No symptomatic, untreated, or uncontrolled CNS metastases

  * CNS metastases previously treated with whole brain radiotherapy allowed
* ECOG performance status (PS) 0-2
* Life expectancy ≥ 12 weeks
* WBC ≥ 3,000/mm³
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin \> 9.0 g/dL
* Total bilirubin \< 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3 times ULN
* ALT and AST ≤ 3 times ULN (≤ 5 times ULN if liver involvement)
* Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
* Proteinuria ≤ +1 on two consecutive dipsticks taken no less than 24hours apart
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective protection during and for up to 8 weeks after completion of study therapy
* QTc interval ≤ 460 msec
* No seizure disorder
* No significant traumatic injury ≤ 4 weeks prior to registration
* No clinically significant infection
* No HIV-positivity
* No second primary malignancy, except for carcinoma in situ of the cervix or nonmelanoma skin cancer, unless prior malignancy was diagnosed and treated ≥ 5 years with no subsequent evidence of recurrence

  * Patients with a history of low grade(Gleason score ≤ 6) localized prostate cancer will be eligible even if diagnosed \< 5 years prior to registration
* No concurrent severe and/or uncontrolled medical conditions, including any of the following:

  * Cardiac arrhythmias
  * Angina pectoris uncontrolled with medication
  * Myocardial infarction within the past 3 months
  * Significant ECG abnormalities
  * Hypertension, labile hypertension, or history of poor compliance with anti-hypertensive medication
  * Congestive heart failure within the past 3 months, unless ejection fraction \> 40%
  * Interstitial pneumonia or extensive, symptomatic interstitial fibrosis of the lung
  * Poorly controlled diabetes
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
* No condition that impairs the ability to swallow AZD0530 tablets, including any of the following:

  * Gastrointestinal tract disease resulting in an inability to take oral medication or requiring IV alimentation
  * Prior surgical procedures affecting absorption of AZD0530 tablets
  * Active peptic ulcer disease
* No serious condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study
* At least 4 weeks since prior major surgery (i.e., laparotomy) or open biopsy
* At least 2 weeks since prior minor surgery
* At least 4 weeks since any prior investigational ancillary therapy (i.e., utilized for a non-FDA-approved indication and in the context of a research investigation)
* At least 7 days since prior use of strong inhibitors of CYP3A4 and no concurrent use for up to 7 days after discontinuation of AZD0530
* Prior nonthoracic palliative radiotherapy allowed
* Concurrent bisphosphonates for treatment of lytic metastatic bone disease allowed at the discretion of the treating physician
* No concurrent prophylactic granulocyte colony-stimulating factor (i.e., G-CSF)
* No concurrent products that stimulate thrombopoiesis
* No concurrent St. John's wort
* No other concurrent chemotherapy, immunotherapy, hormonal therapy,or radiotherapy