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ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer (ZODIAC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00312377
First received: April 6, 2006
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
Results First Received: April 27, 2011  
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: Non-small Cell Lung Cancer
Lung Cancer
Interventions: Drug: Docetaxel
Drug: Vandetanib

  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
First patient enrolled 08 May 2006, last patient enrolled 14 March 2008, cut off date 22 August 2008

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
Vandetanib 100 mg Plus Docetaxel Vandetanib 100 mg oral tablet taken once daily in combination with docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
Placebo Plus Docetaxel Placebo tablet taken once daily plus docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles

Participant Flow:   Overall Study
    Vandetanib 100 mg Plus Docetaxel     Placebo Plus Docetaxel  
STARTED     694 [1]   697 [1]
COMPLETED     50 [2]   29 [2]
NOT COMPLETED     644     668  
Death                 403                 418  
Withdrawal by Subject                 23                 30  
Lost to Follow-up                 9                 12  
Non-compliance                 0                 2  
Randomised but never received treatment                 6                 6  
Discontinue treatment survival follow up                 202                 200  
Site ended participation in study                 1                 0  
[1] randomised patients
[2] ongoing study treatment at data cut-off



  Baseline Characteristics
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Reporting Groups
  Description
Vandetanib 100 mg Plus Docetaxel Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel Placebo plus docetaxel
Total Total of all reporting groups

Baseline Measures
    Vandetanib 100 mg Plus Docetaxel     Placebo Plus Docetaxel     Total  
Number of Participants  
[units: participants]
 		  694     697     1391  
Age  
[units: years]
Mean ( Full Range ) 		  58.5  
  ( 28 to 82 )   		  58.4  
  ( 20 to 82 )   		  58.45  
  ( 20 to 82 )  
Gender  
[units: Participants]
 		     
Female     497     473     970  
Male     197     224     421  



  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS) in the Overall Population   [ Time Frame: RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months ]
  Show Outcome Measure 1

2.  Primary:   Progression-Free Survival (PFS) in the Female Population   [ Time Frame: RECIST tumour assessments carried out every 6 weeks from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first assessed up to 24 months ]
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3.  Secondary:   Overall Survival (OS) in the Overall Population   [ Time Frame: Time to death in months ]
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4.  Secondary:   Overall Survival (OS) in the Female Population   [ Time Frame: Time to death in months ]
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5.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: Each patient was assessed for objective response from the sequence of RECIST scan data up to data cut off. RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression ]
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6.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression ]
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7.  Secondary:   Duration of Response (DoR)   [ Time Frame: RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression ]
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8.  Secondary:   Time to Deterioration of Disease-related Symptoms (TDS) by Functional Assessment of Cancer Therapy - Lung (FACT-L) Lung Cancer Subscale (LCS).   [ Time Frame: FACT-L questionnaires are to be administered every 3 weeks after randomisation ]
  Show Outcome Measure 8

9.  Secondary:   Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Pulmonary Symptom Index (PSI)   [ Time Frame: FACT-L questionnaires are to be administered every 3 weeks after randomisation ]
  Show Outcome Measure 9


  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 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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00312377     History of Changes
Other Study ID Numbers: D4200C00032, 6474IL/0032
Study First Received: April 6, 2006
Results First Received: April 27, 2011
Last Updated: October 5, 2012
Health Authority: United States: Food and Drug Administration