A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer
Inclusion Criteria:
- Histologically or cytologically documented small cell carcinoma of the bronchus,
classified as extensive-stage disease
- Measurable disease or lesions
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Exclusion Criteria:
- Life expectancy of < 12 weeks
- Current, recent, or planned participation in another experimental drug study
- Ongoing or active infection
- Active malignancy other than SCLC or superficial basal/squamous cell carcinoma within
the previous 5 years
- Prior systemic therapy, radiation therapy, or surgery for SCLC
- Inadequate bone marrow function, renal function, or hepatic function
- Serum sodium of < 120 mg/dL
- Inadequately controlled hypertension
- History of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association Class II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to study
enrollment
- History of stroke or transient ischemic attack within 6 months prior to study
enrollment
- Known central nervous system disease, except for brain metastases treated with
whole-brain radiotherapy
- Significant vascular disease or recent peripheral arterial thrombosis within 6 months
prior to study enrollment
- History of hemoptysis within 4 weeks prior to study enrollment
- Evidence of bleeding diathesis or coagulopathy in the absence of therapeutic
anticoagulation
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study enrollment or anticipation of a need for a major surgical procedure
during the course of the study
- Core biopsy or other minor surgical procedure, including placement of a vascular
access device, within 7 days prior to Day 1
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to
study enrollment
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Known hypersensitivity to any component of bevacizumab
- Pregnant (positive pregnancy test) or lactating