Back to resultsA Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)
Primary Purpose
Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bevacizumab
Chemotherapy
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring SCLC, SALUTE, Lung Cancer, Avastin
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo+Chemotherapy
Bevacizumab+Chemotherapy
Arm Description
Chemotherapy = cisplatin (or carboplatin) + etoposide
Chemotherapy = cisplatin (or carboplatin) + etoposide
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS)
Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first.
Secondary Outcome Measures
Overall Survival
Duration of overall survival from randomization until death or loss to follow-up
Percentage of Participants With an Objective Response
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00403403
Brief Title
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
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
SCLC, SALUTE, Lung Cancer, Avastin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo+Chemotherapy
Arm Type
Placebo Comparator
Arm Description
Chemotherapy = cisplatin (or carboplatin) + etoposide
Arm Title
Bevacizumab+Chemotherapy
Arm Type
Experimental
Arm Description
Chemotherapy = cisplatin (or carboplatin) + etoposide
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Chemotherapy = cisplatin (or carboplatin) + etoposide. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first.
Time Frame
Randomization until progression or lost to follow-up (up to 2 years)
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Duration of overall survival from randomization until death or loss to follow-up
Time Frame
Randomization until death or lost of follow-up (up to 27 months)
Title
Percentage of Participants With an Objective Response
Description
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
Time Frame
Randomization until progression or lost to follow-up (up to 2 years)
Title
Number of Participants With an Objective Response
Description
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
Time Frame
Randomization until progression or lost to follow-up (up to 2 years)
Title
Duration of Objective Response
Description
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.
Time Frame
Randomization until progression or lost to follow-up (up to 2 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Karlin, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)
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