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

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00403403
First received: November 21, 2006
Last updated: April 27, 2011
Last verified: April 2011

November 21, 2006
April 27, 2011
March 2007
February 2009   (final data collection date for primary outcome measure)
Progression-free Survival (PFS) [ Time Frame: Randomization until progression or lost to follow-up (up to 2 years) ] [ Designated as safety issue: No ]
Duration of PFS, defined as the time from randomization to disease progression or on-study death, whichever occurred first.
Duration of progression-free survival
Complete list of historical versions of study NCT00403403 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: Randomization until death or lost of follow-up (up to 27 months) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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.
  • Duration of overall survival
  • Objective response rate
  • Duration of objective response
  • Incidence of serious and selected adverse events and events leading to discontinuation.
Not Provided
Not Provided
 
A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)
A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Small Cell Lung Cancer
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
June 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00403403
AVF3995g
Not Provided
David Karlin, M.D., Study Director, Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: David Karlin, M.D. Genentech, Inc.
Genentech, Inc.
April 2011

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