S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Inclusion Criteria

• •Histologically or cytologically confirmed extensive stage small cell lung cancer
• •* Progressive or recurrent disease following one (and only one) standard first-line platinum-containing regimen (cisplatin or carboplatin)
• •Measurable or non-measurable disease per RECIST criteria
• •* Disease must be outside a previously irradiated field OR a new lesion must be inside the irradiated field
• •* Disease must be outside a previously resected area OR a new lesion must be present
• •No known brain metastasis unless the metastasis has been treated and is stable for ≥ 3 months prior to study entry
• •No leptomeningeal involvement or brain stem metastasis
• •Zubrod performance status 0-1
• •ANC ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hemoglobin ≥ 10 g/dL
• •Serum creatinine ≤ 1.5 times upper limit of normal OR creatinine clearance ≥ 60 mL/min
• •Urine protein: creatinine ratio \< 1 OR urine protein \< 500 mg by 24-hour urine collection
• •Not pregnant or nursing
• •Fertile patients must use effective contraception
• •Willing to provide smoking history
• •No evidence of active infection
• •No active bleeding
• •No significant history of bleeding diathesis, including hemoptysis (½ teaspoon of hemoptysis within the past 3 months), or underlying coagulopathy
• •No history of recent arterial embolic events, including any of the following:
• •* Myocardial infarction
• •* Cerebrovascular accident
• •* Transient ischemic attack
• •* Worsening of pre-existing angina within the past 6 months
• •No uncontrolled hypertension (systolic BP \> 150 mm Hg or diastolic BP \> 100 mm Hg)
• •* History of hypertension allowed provided it is controlled on anti-hypertensive medications
• •No history of congestive heart failure
• •No history of encephalitis or encephalopathy of any cause
• •No diverticulitis, gastrointestinal bleeding, or peptic ulcer within the past 3 months
• •No known AIDS or HIV-1 associated complex
• •No known history of immune or immunodeficiency disorders
• •No unstable or pre-existing major medical conditions except for cancer-related abnormalities
• •No other prior malignancy except for any of the following:
• •* Adequately treated basal cell or squamous cell skin cancer
• •* In situ cervical cancer
• •* Adequately treated stage I or II cancer currently in complete remission
• •* Any other cancer from which the patient been disease-free for 5 years
• •Concurrent chronic therapeutic doses of low molecular weight heparin allowed
• •At least 21 days since prior and no concurrent radiotherapy and recovered
• •At least 28 days since prior and no concurrent surgery (e.g., thoracic or other major surgeries) and recovered
• •No prior bevacizumab or other anti-angiogenic therapies including, but not limited to, small molecule tyrosine kinase inhibitors
• •No concurrent enzyme-inducing anticonvulsant drugs
• •* Non-enzyme-inducing anticonvulsant drugs (e.g., Keppra) allowed
• •Concurrent chronic oral anticoagulation therapy allowed provided INR is maintained in the therapeutic range (INR 2-3)