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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00312377
First received: April 6, 2006
Last updated: August 24, 2016
Last verified: August 2016
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 
Overall Participants Analyzed 
[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 ]

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 (91.79%)   630/697 (90.39%) 
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



  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
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