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

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00403403
First received: November 21, 2006
Last updated: April 27, 2011
Last verified: April 2011
  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 small cell lung cancer (SCLC).


Condition Intervention Phase
Small Cell Lung Cancer
Drug: Bevacizumab
Drug: Chemotherapy
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 102
Study Start Date: March 2007
Study Completion Date: June 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo+Chemotherapy
Chemotherapy = cisplatin (or carboplatin) + etoposide
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.
Experimental: Bevacizumab+Chemotherapy
Chemotherapy = cisplatin (or carboplatin) + etoposide
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403403

Sponsors and Collaborators
Genentech
Investigators
Study Director: David Karlin, M.D. Genentech
  More Information

No publications provided

Responsible Party: David Karlin, M.D., Study Director, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00403403     History of Changes
Other Study ID Numbers: AVF3995g
Study First Received: November 21, 2006
Results First Received: January 28, 2010
Last Updated: April 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
SCLC
SALUTE
Lung Cancer
Avastin

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014