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A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00800202
First received: December 1, 2008
Last updated: November 10, 2014
Last verified: November 2014
Results First Received: June 23, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Drug: bevacizumab [Avastin]
Drug: carboplatin
Drug: erlotinib [Tarceva]
Drug: paclitaxel

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bevacizumab+Paclitaxel+Carboplatin Participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (iv) every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 milligrams per square meter (mg/m^2) iv every 3 weeks for 6 cycles and carboplatin Area Under Curve (AUC) 6.0 milligrams per milliliter per minute (mg/mL/min) iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
Bevacizumab+Erlotinib Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib150 milligrams per day (mg/day) administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.

Participant Flow:   Overall Study
    Bevacizumab+Paclitaxel+Carboplatin   Bevacizumab+Erlotinib
STARTED   67   24 
COMPLETED   0   0 
NOT COMPLETED   67   24 
Adverse Event                7                6 
Death                1                0 
Unspecified                5                0 
Disease Progression                54                18 



  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.
The Intent-to-Treat (ITT) population: All participants enrolled in each arm who had at least one post-enrollment evaluation. Participants who were lost to follow-up immediately after enrollment were not included in the ITT population.

Reporting Groups
  Description
Bevacizumab+Paclitaxel+Carboplatin Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
Bevacizumab+Erlotinib Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
Total Total of all reporting groups

Baseline Measures
   Bevacizumab+Paclitaxel+Carboplatin   Bevacizumab+Erlotinib   Total 
Overall Participants Analyzed 
[Units: Participants]
 67   24   91 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.37  (8.31)   54.17  (9.73)   58.74  (9.07) 
Gender 
[Units: Participants]
     
Female   21   13   34 
Male   46   11   57 


  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months   [ Time Frame: 6 months ]

2.  Primary:   Percentage of Participants With Disease Progression or Death   [ Time Frame: Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant ]

3.  Primary:   Time to Disease Progression or Death   [ Time Frame: Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant ]

4.  Secondary:   Percentage of Participants Who Died   [ Time Frame: Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death ]

5.  Secondary:   Probability of Being Alive at 12 and 18 Months   [ Time Frame: Months 12 and 18 ]

6.  Secondary:   Time to Death   [ Time Frame: Day 1 of Cycles 1, 2, 3, 4, 5, 6 and every 3 weeks up to 18 months or until death ]

7.  Secondary:   Percentage of Participants Achieving a Best Overall Response of Complete Response or Partial Response as Assessed by the Investigator Using RECIST   [ Time Frame: Screening, Day 1 of Cycles 3 and 5 and every 2 cycles until end of treatment visit or disease progression or death up to 18 months after enrollment of last participant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann- LaRoche
phone: 1-800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00800202     History of Changes
Other Study ID Numbers: ML21823
2008-006504-33
Study First Received: December 1, 2008
Results First Received: June 23, 2014
Last Updated: November 10, 2014
Health Authority: France:AFSSAPS