Status:
COMPLETED
A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)
Lead Sponsor:
Genentech, Inc.
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or carboplatin) and etoposide i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00403403
Start Date
March 1 2007
End Date
June 1 2009
Last Update
April 29 2011
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