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Pemetrexed Disodium, Gemcitabine, and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

This study has been terminated.
(All data collection has completed.)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Antoinette J. Wozniak, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00438204
First received: February 20, 2007
Last updated: July 15, 2016
Last verified: July 2016
Results First Received: June 4, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Biological: bevacizumab
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium

  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, Gemcitabine Hydrochloride

Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days

Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days

Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.

bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days

gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days

pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.


Participant Flow:   Overall Study
    Bevacizumab, Gemcitabine Hydrochloride
STARTED   39 
COMPLETED   39 
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.
No text entered.

Reporting Groups
  Description
Bevacizumab, Gemcitabine Hydrochloride

Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days

Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days

Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.

bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days

gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days

pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.


Baseline Measures
   Bevacizumab, Gemcitabine Hydrochloride 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   21 
>=65 years   18 
Gender 
[Units: Participants]
 
Female   17 
Male   22 
Region of Enrollment 
[Units: Participants]
 
United States   39 


  Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Up to 12 months ]

2.  Secondary:   Response Rate   [ Time Frame: Every 8 weeks, for up to 54 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Toxicity   [ Time Frame: Every two weeks, for up to 54 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Time to Treatment Failure   [ Time Frame: Every 8 weeks, for up to 54 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Overall Survival   [ Time Frame: Every 8 weeks, for up to 54 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
There were no significant limitations of the trial.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Antionette J. Wozniak, M.D., F.A.C.P.
Organization: Barbara Ann Karmanos Cancer Institute
phone: (313)576-8752
e-mail: wozniakt@karmanos.org



Responsible Party: Antoinette J. Wozniak, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00438204     History of Changes
Other Study ID Numbers: CDR0000531832
P30CA022453 ( US NIH Grant/Contract Award Number )
WSU-2005-008 ( Other Identifier: Barbara Ann Karmanos Cancer Institute )
WSU-036806MP4F ( Other Identifier: Wayne State University - Human Investigation Committee )
Study First Received: February 20, 2007
Results First Received: June 4, 2014
Last Updated: July 15, 2016
Health Authority: United States: Food and Drug Administration
United States: Federal Government