A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)

Phase 2

Completed

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: Chemotherapy; Drug: Bevacizumab; Drug: Placebo

• Registration Number: NCT00403403
• Lead Sponsor: Genentech, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-11-21
• Study First Submitted QC: 2006-11-21
• Study First Posted: 2006-11-23
• Study Start: 2007-03
• Primary Completion: 2009-02
• Study Completion: 2009-06
• Results First Submitted: 2010-01-28
• Results First Submitted QC: 2011-02-01
• Results First Posted: 2011-02-25
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-27
• Last Update Posted: 2011-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo+Chemotherapy	Chemotherapy	Chemotherapy = cisplatin (or carboplatin) + etoposide
Placebo+Chemotherapy	Placebo	Chemotherapy = cisplatin (or carboplatin) + etoposide
Bevacizumab+Chemotherapy	Bevacizumab	Chemotherapy = cisplatin (or carboplatin) + etoposide
Bevacizumab+Chemotherapy	Chemotherapy	Chemotherapy = cisplatin (or carboplatin) + etoposide

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	Randomization until progression or lost to follow-up (up to 2 years)	Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Randomization until death or lost of follow-up (up to 27 months)	Duration of overall survival from randomization until death or loss to follow-up
Percentage of Participants With an Objective Response	Randomization until progression or lost to follow-up (up to 2 years)	Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.; Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST): Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR
Number of Participants With an Objective Response	Randomization until progression or lost to follow-up (up to 2 years)	Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.; Complete Response (CR), Partial Response (PR), Incomplete Response (IR), Stable Disease (SD) (per RECIST): Target Lesions Non-Target Lesions New Lesions Overall Response CR CR No CR CR IR/SD No PR PR Non-PD No PR
Duration of Objective Response	Randomization until progression or lost to follow-up (up to 2 years)	Duration of response was defined as time from the first response date to disease progression or on-study death (i.e., death occurring any time from randomization to 30 days after the final treatment with bevacizumab/placebo). Objective response was defined as a complete or partial response (per RECIST) determined by two investigator assessments conducted at least 4 weeks apart.