A Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer (BRIDGE)

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00318136
First received: April 24, 2006
Last updated: May 5, 2010
Last verified: May 2010
Results First Received: March 19, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-small Cell Lung Cancer
Interventions: Drug: Bevacizumab
Drug: Carboplatin
Drug: Paclitaxel

  Participant Flow
  Hide Participant Flow

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
Treated With Bevacizumab Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).

Participant Flow:   Overall Study
    Treated With Bevacizumab  
STARTED     47  
COMPLETED     2  
NOT COMPLETED     45  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Treated With Bevacizumab Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).

Baseline Measures
    Treated With Bevacizumab  
Number of Participants  
[units: participants]
  31  
Age [1]
[units: years]
Mean ± Standard Deviation
  65.0  ± 7.9  
Gender [1]
[units: participants]
 
Female     10  
Male     21  
[1] Of the 47 enrolled subjects, 31 met the protocol-specified criteria and received bevacizumab.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events   [ Time Frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death ]

2.  Secondary:   Selected Adverse Events   [ Time Frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death ]

3.  Secondary:   Adverse Events That Led to Discontinuation of Bevacizumab   [ Time Frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death ]

4.  Secondary:   Progression-free Survival   [ Time Frame: Length of study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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: Genentech, Inc.
phone: 800-821-8590


No publications provided


Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00318136     History of Changes
Other Study ID Numbers: AVF3744g
Study First Received: April 24, 2006
Results First Received: March 19, 2010
Last Updated: May 5, 2010
Health Authority: United States: Food and Drug Administration