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A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)
This study is currently recruiting participants.
Verified by Genentech, October 2008
Sponsored by: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00403403
  Purpose

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 SCLC.


Condition Intervention Phase
Small Cell Lung Cancer
Drug: bevacizumab
Drug: chemotherapy
Drug: placebo
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title: A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Until death or loss to follow-up ] [ Designated as safety issue: No ]
  • Objective response and duration of response [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Serious and select adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2007
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: bevacizumab
Intravenous repeating dose
Drug: chemotherapy
Repeating dose
2: Placebo Comparator Drug: chemotherapy
Repeating dose
Drug: placebo
Intravenous repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed Informed Consent Form
  • Histologically or cytologically documented small cell carcinoma of the bronchus, classified as extensive-stage disease
  • Measurable disease or lesions
  • Age ≥ 18 years
  • ECOG performance status of 0, 1, or 2
  • Ability and capacity to comply with study and follow-up procedures

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
  • Any other medical condition deemed by the clinician to be likely to interfere with a patient's ability to sign the Informed Consent Form or cooperate and participate in the study, or to interfere with the interpretation of the results
  • Inadequately controlled hypertension
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association Class II or greater CHF
  • 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 CNS 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
  • Proteinuria, as demonstrated by a UPC ratio ≥ 1 at screening
  • Known hypersensitivity to any component of bevacizumab
  • Pregnant (positive pregnancy test) or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403403

Contacts
Contact: Genentech Trial Information Support Line 888-662-6728

  Show 69 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Jane Huang, M.D. Genentech
  More Information

Responsible Party: Genentech, Inc. ( Jane Huang, M.D., Study Director )
Study ID Numbers: AVF3995g
Study First Received: November 21, 2006
Last Updated: October 3, 2008
ClinicalTrials.gov Identifier: NCT00403403  
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
SCLC
SALUTE
Lung Cancer
Avastin

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Bevacizumab
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009