Phase 2
N=102
A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)
Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00403403 ↗Enrolled (actual)
102
Serious AEs
31.6%
Results posted
Feb 2011
Primary outcome: Primary: Progression-free Survival (PFS) — 4.4; 5.5 Months — p=0.0097
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (Drug); Chemotherapy (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
4.4; 5.5 | 0.0097 sig |
| SECONDARY Overall Survival |
10.9; 9.4 | 0.6054 |
| SECONDARY Percentage of Participants With an Objective Response |
48.0; 57.7 | 0.3269 |
| SECONDARY Number of Participants With an Objective Response |
24; 30 | — |
| SECONDARY Duration of Objective Response |
3.2; 4.7 | 0.0011 sig |
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 in patients with previously untreated extensive-stage small cell lung cancer (SCLC).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00403403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.