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
Results First Received: January 28, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Small Cell Lung Cancer
Interventions: Drug: Bevacizumab
Drug: Chemotherapy
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo+Chemotherapy Chemotherapy = cisplatin (or carboplatin) + etoposide. 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. 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.
Bevacizumab+Chemotherapy Chemotherapy = cisplatin (or carboplatin) + etoposide. 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. 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.

Participant Flow:   Overall Study
    Placebo+Chemotherapy     Bevacizumab+Chemotherapy  
STARTED     50     52  
Safety-Evaluable Patients     47     51  
COMPLETED     50     52  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo+Chemotherapy Chemotherapy = cisplatin (or carboplatin) + etoposide. 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. 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.
Bevacizumab+Chemotherapy Chemotherapy = cisplatin (or carboplatin) + etoposide. 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. 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.
Total Total of all reporting groups

Baseline Measures
    Placebo+Chemotherapy     Bevacizumab+Chemotherapy     Total  
Number of Participants  
[units: participants]
  50     52     102  
Age  
[units: years]
Mean ± Standard Deviation
  64.0  ± 10.0     61.3  ± 8.5     62.7  ± 9.3  
Gender  
[units: participants]
     
Female     20     26     46  
Male     30     26     56  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Randomization until progression or lost to follow-up (up to 2 years) ]

2.  Secondary:   Overall Survival   [ Time Frame: Randomization until death or lost of follow-up (up to 27 months) ]

3.  Secondary:   Percentage of Participants With an Objective Response   [ Time Frame: Randomization until progression or lost to follow-up (up to 2 years) ]

4.  Secondary:   Number of Participants With an Objective Response   [ Time Frame: Randomization until progression or lost to follow-up (up to 2 years) ]

5.  Secondary:   Duration of Objective Response   [ Time Frame: Randomization until progression or lost to follow-up (up to 2 years) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Genentech, Inc.
phone: 800-821-8590


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