Carboplatin and Gemcitabine With Bevacizumab Every 2 Weeks for Stage IIIb/IV Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Genentech, Inc.
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00400803
First received: November 15, 2006
Last updated: October 22, 2012
Last verified: October 2012
Results First Received: November 10, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Intervention: Drug: Gemcitabine, Carboplatin, 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
38 Patients with stage IIIb/IV non-small cell lung cancer were recruited at two institutions in Minnesota: Masonic Cancer Center at University of Minnesota and North Memorial Research Center (Hubert H. Humphrey Cancer Center).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Outcome data analysis is only available for 35 of 38 patients in database. Three patients are excluded: 1 never enrolled, 1 has no record of treatment and fup, 1 has no treatment fup.

Reporting Groups
  Description
Intent To Treat - Lung Cancer Patients Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.

Participant Flow:   Overall Study
    Intent To Treat - Lung Cancer Patients  
STARTED     35  
COMPLETED     35  
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
Intent To Treat - Lung Cancer Patients Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.

Baseline Measures
    Intent To Treat - Lung Cancer Patients  
Number of Participants  
[units: participants]
  35  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     20  
>=65 years     15  
Age  
[units: years]
Median ( Full Range )
  65  
  ( 39 to 76 )  
Gender  
[units: participants]
 
Female     15  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     35  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Progression   [ Time Frame: From Enrollment Through 2 Years ]

2.  Secondary:   Best Overall Response by Cycle   [ Time Frame: After Cycle 4, Cycle 6 and Cycle 7 of Therapy ]

3.  Secondary:   Duration of Response   [ Time Frame: From Enrollment through Date of First Documented Disease Progression or Date of Death From Any Cause, Whichever Came First, Up to 100 Months ]

4.  Secondary:   Overall Survival Time   [ Time Frame: Baseline to Death ]

5.  Secondary:   Time to Best Response   [ Time Frame: From Enrollment to First Tumor Response ]


  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
Outcome data is available for 35 (of 38) patients only.


  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: Arkadiusz Dudek, M.D.
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-624-0123
e-mail: dudek002@umn.edu


No publications provided by Masonic Cancer Center, University of Minnesota

Publications automatically indexed to this study:

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00400803     History of Changes
Other Study ID Numbers: 2007UC021, HHH2L06, AVF3982s, B9E-US-X463
Study First Received: November 15, 2006
Results First Received: November 10, 2011
Last Updated: October 22, 2012
Health Authority: United States: Food and Drug Administration