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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00403403
Recruitment Status : Completed
First Posted : November 23, 2006
Results First Posted : February 25, 2011
Last Update Posted : April 29, 2011
Sponsor:
Information provided by:
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE November 21, 2006
First Posted Date  ICMJE November 23, 2006
Results First Submitted Date  ICMJE January 28, 2010
Results First Posted Date  ICMJE February 25, 2011
Last Update Posted Date April 29, 2011
Study Start Date  ICMJE March 2007
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2011)
Progression-free Survival (PFS) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2006)
Duration of progression-free survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2011)
  • Overall Survival [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2006)
  • Duration of overall survival
  • Objective response rate
  • Duration of objective response
  • Incidence of serious and selected adverse events and events leading to discontinuation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)
Official Title  ICMJE A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Bevacizumab
    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.
  • Drug: Chemotherapy
    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.
  • Drug: Placebo
    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.
Study Arms  ICMJE
  • Placebo Comparator: Placebo+Chemotherapy
    Chemotherapy = cisplatin (or carboplatin) + etoposide
    Interventions:
    • Drug: Chemotherapy
    • Drug: Placebo
  • Experimental: Bevacizumab+Chemotherapy
    Chemotherapy = cisplatin (or carboplatin) + etoposide
    Interventions:
    • Drug: Bevacizumab
    • Drug: Chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2009)
102
Original Enrollment  ICMJE
 (submitted: November 21, 2006)
100
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00403403
Other Study ID Numbers  ICMJE AVF3995g
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Karlin, M.D., Study Director, Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Karlin, M.D. Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP