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Study of Vandetanib Combined With Chemotherapy to Treat Advanced Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
PrECOG, LLC.
ClinicalTrials.gov Identifier:
NCT00687297
First received: May 27, 2008
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
Results First Received: June 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Lung Cancer
Non Small Cell Lung Cancer
Interventions: Drug: vandetanib induction
Drug: Docetaxel
Drug: Carboplatin
Drug: Placebo
Drug: Vandetanib maintenance

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Randomized to Vandetanib Maintenance Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
Randomized to Placebo Maintenance Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]

Participant Flow for 3 periods

 Period 1:   Randomization
    Randomized to Vandetanib Maintenance     Randomized to Placebo Maintenance  
STARTED     80     82  
COMPLETED     77     81  
NOT COMPLETED     3     1  
Withdrawal by Subject                 2                 0  
Withdrew before treatment, ineligible                 1                 1  

Period 2:   Induction
    Randomized to Vandetanib Maintenance     Randomized to Placebo Maintenance  
STARTED     77     81  
COMPLETED     32     26  
NOT COMPLETED     45     55  
Withdrawal by Subject                 4                 4  
Adverse Event                 16                 15  
Death                 7                 11  
Lack of Efficacy                 17                 21  
Ineligible                 0                 1  
Patient Noncompliance                 1                 0  
Physician Decision                 0                 2  
Unknown                 0                 1  

Period 3:   Maintenance
    Randomized to Vandetanib Maintenance     Randomized to Placebo Maintenance  
STARTED     32     26  
COMPLETED     29     25  
NOT COMPLETED     3     1  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Progression-free Survival   [ Time Frame: Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance)) ]
  Show Outcome Measure 1

2.  Secondary:   Objective Response Rate   [ Time Frame: Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance)) ]
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3.  Secondary:   Progression-free Survival   [ Time Frame: every 2 cycles (every 6 weeks during induction, every 8 weeks during maintenance) ]
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  Serious Adverse Events
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  Other Adverse Events
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
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Results Point of Contact:  
Name/Title: Study Statistician
Organization: PrECOG
phone: 617-632-3633
e-mail: jmanola@jimmy.harvard.edu


No publications provided


Responsible Party: PrECOG, LLC.
ClinicalTrials.gov Identifier: NCT00687297     History of Changes
Other Study ID Numbers: PrE0501, IRUSZACT0088
Study First Received: May 27, 2008
Results First Received: June 6, 2012
Last Updated: November 28, 2012
Health Authority: United States: Food and Drug Administration