Phase II Study Alimta and Gemzar + Avastin as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV NSCLC

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Genentech
Information provided by (Responsible Party):
Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier:
NCT00517595
First received: August 16, 2007
Last updated: March 8, 2012
Last verified: March 2012
Results First Received: October 11, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Intervention: Drug: Pemetrexed and Gemcitabine plus Bevacizumab

  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
9 community oncology research sites across the US within the ACORN network participated in this study. Enrollment started in August 2007 and was completed in September 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Informed consent was obtained from all subjects. All subjects underwent screening procedures to verify eligibility.

Reporting Groups
  Description
Pemetrexed, Gemcitabine, and Bevacizumab All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.

Participant Flow:   Overall Study
    Pemetrexed, Gemcitabine, and Bevacizumab  
STARTED     48  
COMPLETED     48  
NOT COMPLETED     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.
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Reporting Groups
  Description
Pemetrexed, Gemcitabine, and Bevacizumab All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.

Baseline Measures
    Pemetrexed, Gemcitabine, and Bevacizumab  
Number of Participants  
[units: participants]
  48  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     48  
Age  
[units: years]
Mean ± Standard Deviation
  72.60  ± 5.20  
Gender  
[units: participants]
 
Female     21  
Male     27  
Region of Enrollment  
[units: participants]
 
United States     48  



  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months. ]

2.  Secondary:   Time to Progression (TTP)   [ Time Frame: TTP was measured from day 1 of treatment until time of progression (assessed every 8 weeks), assessed up to 15 months. ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: OS was measured from day 1 of treatment until time of death, assessed up to 20 months. ]

4.  Secondary:   Overall Response   [ Time Frame: Response to treatment was assessed after every 8 weeks of treatment, up to 50 weeks. ]

5.  Other Pre-specified:   Progression Free Survival (PFS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status   [ Time Frame: PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months. ]

6.  Other Pre-specified:   Overall Survival (OS) by Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status   [ Time Frame: OS was measured from day 1 of treatment until time of death, assessed up to 20 months. ]


  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: Vice President of Scientific Affairs
Organization: Accelerated Community Oncology Research Network, Inc.
phone: 901-435-5570
e-mail: mwalker@acorncro.com


No publications provided


Responsible Party: Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier: NCT00517595     History of Changes
Other Study ID Numbers: ALJBNSCLC0602
Study First Received: August 16, 2007
Results First Received: October 11, 2011
Last Updated: March 8, 2012
Health Authority: United States: Institutional Review Board