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
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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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
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
  Show All Outcome Measures

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 ]

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 ]

3.  Secondary:   Overall Survival (OS) in the Overall Population   [ Time Frame: Time to death in months ]

4.  Secondary:   Overall Survival (OS) in the Female Population   [ Time Frame: Time to death in months ]

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 ]

6.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression ]

7.  Secondary:   Duration of Response (DoR)   [ Time Frame: RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression ]

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Vandetanib 100 mg Plus Docetaxel Vandetanib 100 mg plus docetaxel
Placebo Plus Docetaxel Placebo plus docetaxel

Other Adverse Events
    Vandetanib 100 mg Plus Docetaxel     Placebo Plus Docetaxel  
Total, other (not including serious) adverse events      
# participants affected / at risk     637/694     630/697  
Blood and lymphatic system disorders      
Neutropenia † 1    
# participants affected / at risk     212/694 (30.55%)     174/697 (24.96%)  
Leukopenia † 1    
# participants affected / at risk     125/694 (18.01%)     106/697 (15.21%)  
Anaemia † 1    
# participants affected / at risk     68/694 (9.80%)     98/697 (14.06%)  
Gastrointestinal disorders      
Diarrhoea † 1    
# participants affected / at risk     284/694 (40.92%)     218/697 (31.28%)  
Nausea † 1    
# participants affected / at risk     158/694 (22.77%)     221/697 (31.71%)  
Vomiting † 1    
# participants affected / at risk     105/694 (15.13%)     141/697 (20.23%)  
Constipation † 1    
# participants affected / at risk     119/694 (17.15%)     140/697 (20.09%)  
Stomatitis † 1    
# participants affected / at risk     80/694 (11.53%)     80/697 (11.48%)  
Abdominal Pain † 1    
# participants affected / at risk     41/694 (5.91%)     50/697 (7.17%)  
Dyspepsia † 1    
# participants affected / at risk     37/694 (5.33%)     25/697 (3.59%)  
Abdominal Pain Upper † 1    
# participants affected / at risk     30/694 (4.32%)     36/697 (5.16%)  
General disorders      
Fatigue † 1    
# participants affected / at risk     208/694 (29.97%)     214/697 (30.70%)  
Pyrexia † 1    
# participants affected / at risk     127/694 (18.30%)     110/697 (15.78%)  
Asthenia † 1    
# participants affected / at risk     105/694 (15.13%)     90/697 (12.91%)  
Oedema Peripheral † 1    
# participants affected / at risk     49/694 (7.06%)     57/697 (8.18%)  
Mucosal Inflammation † 1    
# participants affected / at risk     49/694 (7.06%)     38/697 (5.45%)  
Infections and infestations      
Nasopharyngitis † 1    
# participants affected / at risk     41/694 (5.91%)     37/697 (5.31%)  
Weight Decreased † 1    
# participants affected / at risk     54/694 (7.78%)     41/697 (5.88%)  
Metabolism and nutrition disorders      
Anorexia † 1    
# participants affected / at risk     199/694 (28.67%)     204/697 (29.27%)  
Musculoskeletal and connective tissue disorders      
Myalgia † 1    
# participants affected / at risk     90/694 (12.97%)     78/697 (11.19%)  
Back Pain † 1    
# participants affected / at risk     51/694 (7.35%)     62/697 (8.90%)  
Arthralgia † 1    
# participants affected / at risk     61/694 (8.79%)     52/697 (7.46%)  
Pain In Extremity † 1    
# participants affected / at risk     39/694 (5.62%)     31/697 (4.45%)  
Musculoskeletal Pain † 1    
# participants affected / at risk     35/694 (5.04%)     30/697 (4.30%)  
Nervous system disorders      
Headache † 1    
# participants affected / at risk     58/694 (8.36%)     62/697 (8.90%)  
Dizziness † 1    
# participants affected / at risk     43/694 (6.20%)     58/697 (8.32%)  
Dysgeusia † 1    
# participants affected / at risk     40/694 (5.76%)     49/697 (7.03%)  
Peripheral Sensory Neuropathy † 1    
# participants affected / at risk     42/694 (6.05%)     48/697 (6.89%)  
Paraesthesia † 1    
# participants affected / at risk     42/694 (6.05%)     42/697 (6.03%)  
Psychiatric disorders      
Insomnia † 1    
# participants affected / at risk     95/694 (13.69%)     73/697 (10.47%)  
Respiratory, thoracic and mediastinal disorders      
Cough † 1    
# participants affected / at risk     130/694 (18.73%)     133/697 (19.08%)  
Dyspnoea † 1    
# participants affected / at risk     102/694 (14.70%)     122/697 (17.50%)  
Epistaxis † 1    
# participants affected / at risk     50/694 (7.20%)     27/697 (3.87%)  
Haemoptysis † 1    
# participants affected / at risk     37/694 (5.33%)     45/697 (6.46%)  
Dysphonia † 1    
# participants affected / at risk     41/694 (5.91%)     20/697 (2.87%)  
Hiccups † 1    
# participants affected / at risk     30/694 (4.32%)     41/697 (5.88%)  
Skin and subcutaneous tissue disorders      
Rash † 1    
# participants affected / at risk     282/694 (40.63%)     166/697 (23.82%)  
Alopecia † 1    
# participants affected / at risk     230/694 (33.14%)     240/697 (34.43%)  
Pruritus † 1    
# participants affected / at risk     65/694 (9.37%)     42/697 (6.03%)  
Nail Disorder † 1    
# participants affected / at risk     52/694 (7.49%)     46/697 (6.60%)  
Dry Skin † 1    
# participants affected / at risk     45/694 (6.48%)     30/697 (4.30%)  
Photosensitivity Reaction † 1    
# participants affected / at risk     42/694 (6.05%)     1/697 (0.14%)  
Vascular disorders      
Hypertension † 1    
# participants affected / at risk     41/694 (5.91%)     13/697 (1.87%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 11.0



  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