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 researchinvestigation)
• 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