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