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 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