Clinical trial NCT00403403: A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)
Official title: A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Keywords: SCLC
SALUTE
Lung Cancer
Avastin
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2006-11-23
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Randomization until progression or lost to follow-up (up to 2 years)
Secondary outcomes:
measure: Overall Survival
timeFrame: Randomization until death or lost of follow-up (up to 27 months)
measure: Percentage of Participants With an Objective Response
timeFrame: Randomization until progression or lost to follow-up (up to 2 years)
measure: Number of Participants With an Objective Response
timeFrame: Randomization until progression or lost to follow-up (up to 2 years)
measure: Duration of Objective Response
timeFrame: Randomization until progression or lost to follow-up (up to 2 years)
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: David Karlin, M.D.
role: STUDY_DIRECTOR
References: