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