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Phase 2 Trial of Bevacizumab in Combination With Pemetrexed

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Genentech, Inc.
Information provided by (Responsible Party):
Heather Wakelee, Stanford University
ClinicalTrials.gov Identifier:
NCT00227019
First received: September 8, 2005
Last updated: January 12, 2017
Last verified: January 2017
Results First Received: April 20, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Non-small Cell Lung Cancer (NSCLC)
Lung Cancer
Neoplasm Metastasis
Interventions: Drug: Bevacizumab
Drug: Pemetrexed
Drug: Vitamin B12
Drug: Folate
Drug: Dexamethasone

  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
Bevacizumab Plus Pemetrexed Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.

Participant Flow:   Overall Study
    Bevacizumab Plus Pemetrexed
STARTED   16 
COMPLETED   16 
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.
Adult patients with advanced stage nonsquamous NSCLC and stable treated metastatic disease in the brain were eligible if they were candidates for second-line therapy after progression on a platinum doublet regimen for advanced disease.

Reporting Groups
  Description
Bevacizumab Plus Pemetrexed Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.

Baseline Measures
   Bevacizumab Plus Pemetrexed 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Years]
Median (Full Range)
 60 
 (33 to 78) 
Gender 
[Units: Participants]
Count of Participants
 
Female      9  56.3% 
Male      7  43.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      6  37.5% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      10  62.5% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Eastern Cooperative Oncology Group (ECOG) performance status [1] 
[Units: Participants]
 
0-1   15 
 1 
[1]

ECOG performance status

  • 0 = Fully active, able to carry on all pre-disease performance without restriction
  • 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work
  • 2 = Unable to work, must sit or lie > 50% waking hours
  • 3 = Capable of limited selfcare; confined to bed or chair > 50% waking hours
  • 4 = Completely disabled; cannot carry on any selfcare; totally confined to bed/chair
  • 5 = Deceased
Histology [1] 
[Units: Participants]
 
Adeno-carcinoma   12 
Large cell carinoma   0 
Not otherwise specified (NOS)   4 
[1] Histology refers to the type of non-small cell lung cancer (NSCLC)


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Central Nervous System (CNS) Hemorrhagic Events   [ Time Frame: 18 months ]

2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: 18 months ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: 18 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 NOT 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.


Results Point of Contact:  
Name/Title: Heather Wakelee, MD
Organization: Stanford University
phone: 650-736-7221
e-mail: hwakelee@stanford.edu



Responsible Party: Heather Wakelee, Stanford University
ClinicalTrials.gov Identifier: NCT00227019     History of Changes
Other Study ID Numbers: IRB-00892
95913 ( Other Identifier: Stanford University Alternate IRB Approval Number )
LUN0014 ( Other Identifier: OnCore )
Study First Received: September 8, 2005
Results First Received: April 20, 2016
Last Updated: January 12, 2017