Back to resultsZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer (ZODIAC)
Primary Purpose
Non-small Cell Lung Cancer, Lung Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Docetaxel
Vandetanib
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small cell lung cancer, NSCLC
Eligibility Criteria
Inclusion Criteria: Lung cancer patients who answer true to the following statements are eligible to join this clinical study. I have a confirmed diagnosis of locally advanced or metastatic non small cell lung cancer (Stage IIIb - IV) I have had 1st line anti-cancer therapy. Previous treatment with Avastin (bevacizumab) in first line NSCLC is allowed. Exclusion Criteria: Lung cancer patients who answer true to the following are NOT eligible to join this clinical study. I do not have non small cell lung cancer (NSCLC) I have received treatment with docetaxel (Taxotere). Prior treatment with paclitaxel is acceptable. I have received 2nd line anti-cancer therapy (For example, patients with previous 2nd line non small cell lung cancer (NSCLC) treatment with Tarceva (erlotinib, OSI-744), Alimta (pemetrexed) are not eligible) I have been treated with VEGFR-tyrosine kinase inhibitors (TKIs) (sunitinib, sorafenib, other VEGF TKIs). Previous treatment with Avastin (bevacizumab) in 1st line non small cell lung cancer is permitted. I have a history of uncontrolled irregular heartbeat I have a history of high blood pressure which has not been controlled with medication If you are unsure of the meaning of the inclusion and exclusion criteria above, please contact the call center number for help.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Docetaxel monotherapy
Vandetanib + Docetaxel
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS) in the Overall Population
Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.
Progression-Free Survival (PFS) in the Female Population
Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.
Secondary Outcome Measures
Overall Survival (OS) in the Overall Population
Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).
Overall Survival (OS) in the Female Population
Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).
Objective Response Rate (ORR)
The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.
Disease Control Rate (DCR)
Disease control rate is defined as the number of patients who achieved disease control at least 6 weeks following randomisation. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 6 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 6 is assigned to patients who have not responded and have no evidence of progression at least 6 weeks after randomisation.
Duration of Response (DoR)
Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)
Time to Deterioration of Disease-related Symptoms (TDS) by Functional Assessment of Cancer Therapy - Lung (FACT-L) Lung Cancer Subscale (LCS).
The lung cancer subscale (LCS) consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items.
Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.
A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days.
Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Pulmonary Symptom Index (PSI)
The pulmonary symptom index (PSI) consists of 4 items of the LCS relating to pulmonary symptoms (i.e. 3 items relating to breathing/dyspnea, and 1 item relating to cough). The PSI score is the sum of the scores from the 4 items.
Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.
A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days.
Full Information
NCT ID
NCT00312377
First Posted
April 6, 2006
Last Updated
August 24, 2016
Sponsor
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00312377
Brief Title
ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer
Acronym
ZODIAC
Official Title
A Phase III, Randomized, Double-Blinded, Multi-Center, Study to Assess the Efficacy of Docetaxel (TAXOTERE™) in Combination With ZD6474 (ZACTIMA™) Versus Docetaxel (TAXOTERE™) With Placebo in Subjects With Locally Advanced or Metastatic NSCLC
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
5. Study Description
Brief Summary
This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets the blood supply to a cancer tumour (through it's anti-vascular endothelial growth factor receptor (VEGFR) properties) and the tumour cells themselves (through it's anti-endothelial growth factor receptor (EGFR) actions). This study will look at the effects of vandetanib in lung cancer patients who have had their cancer re-appear after treatment with standard chemotherapy.
This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can deliver longer improved progression free survival and improved overall survival than docetaxel (Taxotere) alone.
All patients participating this clinical study will receive treatment with docetaxel, a commonly used treatment for recurrent non-small cell lung cancer.
In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF agent.
Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR) inhibition, when used with standard chemotherapy, can lead to increased survival in advanced non-small cell lung cancer (NSCLC) patients.
Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib (Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour cells and stopping them from dividing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Lung Cancer
Keywords
Non-small cell lung cancer, NSCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1690 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Docetaxel monotherapy
Arm Title
2
Arm Type
Experimental
Arm Description
Vandetanib + Docetaxel
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
TAXOTERE™
Intervention Description
infusion
Intervention Type
Drug
Intervention Name(s)
Vandetanib
Other Intervention Name(s)
ZACTIMA™, ZD6474
Intervention Description
oral
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) in the Overall Population
Description
Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.
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
Title
Progression-Free Survival (PFS) in the Female Population
Description
Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.
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
Secondary Outcome Measure Information:
Title
Overall Survival (OS) in the Overall Population
Description
Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).
Time Frame
Time to death in months
Title
Overall Survival (OS) in the Female Population
Description
Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown).
Time Frame
Time to death in months
Title
Objective Response Rate (ORR)
Description
The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions.
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
Title
Disease Control Rate (DCR)
Description
Disease control rate is defined as the number of patients who achieved disease control at least 6 weeks following randomisation. Disease control at 6 weeks is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 6 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 6 is assigned to patients who have not responded and have no evidence of progression at least 6 weeks after randomisation.
Time Frame
RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
Title
Duration of Response (DoR)
Description
Response is defined as a confirmed best objective response of CR or PR. Duration of response is defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression (provided death is within 3 months of last RECIST assessment)
Time Frame
RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression
Title
Time to Deterioration of Disease-related Symptoms (TDS) by Functional Assessment of Cancer Therapy - Lung (FACT-L) Lung Cancer Subscale (LCS).
Description
The lung cancer subscale (LCS) consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items.
Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.
A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days.
Time Frame
FACT-L questionnaires are to be administered every 3 weeks after randomisation
Title
Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Pulmonary Symptom Index (PSI)
Description
The pulmonary symptom index (PSI) consists of 4 items of the LCS relating to pulmonary symptoms (i.e. 3 items relating to breathing/dyspnea, and 1 item relating to cough). The PSI score is the sum of the scores from the 4 items.
Time to deterioration is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 21 days.
A patient will be defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 21 days.
Time Frame
FACT-L questionnaires are to be administered every 3 weeks after randomisation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Lung cancer patients who answer true to the following statements are eligible to join this clinical study.
I have a confirmed diagnosis of locally advanced or metastatic non small cell lung cancer (Stage IIIb - IV)
I have had 1st line anti-cancer therapy. Previous treatment with Avastin (bevacizumab) in first line NSCLC is allowed.
Exclusion Criteria:
Lung cancer patients who answer true to the following are NOT eligible to join this clinical study.
I do not have non small cell lung cancer (NSCLC)
I have received treatment with docetaxel (Taxotere). Prior treatment with paclitaxel is acceptable.
I have received 2nd line anti-cancer therapy (For example, patients with previous 2nd line non small cell lung cancer (NSCLC) treatment with Tarceva (erlotinib, OSI-744), Alimta (pemetrexed) are not eligible)
I have been treated with VEGFR-tyrosine kinase inhibitors (TKIs) (sunitinib, sorafenib, other VEGF TKIs). Previous treatment with Avastin (bevacizumab) in 1st line non small cell lung cancer is permitted.
I have a history of uncontrolled irregular heartbeat
I have a history of high blood pressure which has not been controlled with medication If you are unsure of the meaning of the inclusion and exclusion criteria above, please contact the call center number for help.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Contact-US@sanofi.com
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
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Fullerton
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California
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United States
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Los Angeles
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California
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United States
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Northridge
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California
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United States
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Colorado Springs
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Colorado
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United States
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Norwalk
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United States
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Ocala
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Marietta
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United States
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Joliet
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United States
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Park Ridge
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United States
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Hutchinson
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Louisville
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Boston
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Ann Arbor
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Henderson
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Albany
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New York
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United States
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Armonk
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New York
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United States
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New York
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New York
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United States
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Durham
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North Carolina
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United States
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Hickory
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North Carolina
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United States
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Portland
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Oregon
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United States
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Austin
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Texas
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United States
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Houston
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Texas
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United States
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Ogden
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Utah
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United States
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Alexandria
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Virginia
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United States
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Salem
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Virginia
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United States
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Vancouver
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Washington
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United States
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Bahía Blanca
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Argentina
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Capital Federal
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Argentina
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Ciudad de Buenos Aires
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Argentina
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Mendoza
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Argentina
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Rosario
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Argentina
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Graz
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Austria
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Grimmenstein
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Wels
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Austria
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Wien
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Austria
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Brussels (Jette)
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Belgium
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Brussels (Woluwé-St-Lambert)
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Belgium
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Edegem
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Belgium
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Genk
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Belgium
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Liege
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Belgium
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Fortaleza
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Brazil
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Goiânia
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Brazil
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Edmonton
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Alberta
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Canada
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Moncton
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New Brunswick
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Canada
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Halifax
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Nova Scotia
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Canada
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Kitchener
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Ontario
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Canada
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London
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Ontario
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Canada
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Toronto
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Ontario
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Canada
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Laval
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Quebec
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Canada
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Quebec
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Canada
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Beijing
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China
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Chongqing
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China
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Guangzhou
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China
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Nanjing
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China
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Shanghai
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China
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Wuhan
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China
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Herlev
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Denmark
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København Ø
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Denmark
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Odense
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Denmark
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Roskilde
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Denmark
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Vejle
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Denmark
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Bordeaux Cedex
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France
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Boulogne Billancourt
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France
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Caen Cedex
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France
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Dijon
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France
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Nancy
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France
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Paris
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France
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Pierre Benite Cedex
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France
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Saint Herblain
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France
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Bad Berka
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Germany
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Berlin
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Germany
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Essen
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Germany
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Großhansdorf
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Germany
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Halle
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Köln
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Germany
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Oldenburg
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Germany
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Ulm
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Germany
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Wiesbaden
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Germany
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Athens
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Greece
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Heraklion
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Greece
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Ahmedabad
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India
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Chennai
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India
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Hyderabad
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India
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Kolkata
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India
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New Delhi
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India
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Pune
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India
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Vellore
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India
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Jakarta Timur
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Indonesia
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Yogyakarta
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Indonesia
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Ancona
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Italy
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Avellino
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Italy
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Bologna
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Italy
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Genova
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Italy
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Mantova
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Italy
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Napoli
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Italy
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Orbassano
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Italy
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Parma
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Italy
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Perugia
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Italy
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Pisa
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Italy
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Reggio Emilia
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Italy
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Akashi-shi
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Japan
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Fukuoka-shi
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Japan
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Fukuoka
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Japan
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Isehara-shi
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Japan
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Kobe-shi
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Japan
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Koto-ku
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Japan
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Kumamoto-shi
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Japan
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Matsuyama-shi
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Japan
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Nagoya-shi
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Japan
Facility Name
Research Site
City
Okayama-shi
Country
Japan
Facility Name
Research Site
City
Okazaki-shi
Country
Japan
Facility Name
Research Site
City
Osaka-shi
Country
Japan
Facility Name
Research Site
City
Osakasayama-shi
Country
Japan
Facility Name
Research Site
City
Sakai-shi
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
Country
Japan
Facility Name
Research Site
City
Sunto-gun
Country
Japan
Facility Name
Research Site
City
Toyonaka
Country
Japan
Facility Name
Research Site
City
Ube-shi
Country
Japan
Facility Name
Research Site
City
Utsunomiya-shi
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
Country
Japan
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Kubang Kerian
Country
Malaysia
Facility Name
Research Site
City
Nilai
Country
Malaysia
Facility Name
Research Site
City
Penang
Country
Malaysia
Facility Name
Research Site
City
Durango
Country
Mexico
Facility Name
Research Site
City
Morelia
Country
Mexico
Facility Name
Research Site
City
Toluca
Country
Mexico
Facility Name
Research Site
City
Amsterdam
Country
Netherlands
Facility Name
Research Site
City
Den Bosch
Country
Netherlands
Facility Name
Research Site
City
Groningen
Country
Netherlands
Facility Name
Research Site
City
Maastricht
Country
Netherlands
Facility Name
Research Site
City
Coimbra
Country
Portugal
Facility Name
Research Site
City
Funchal
Country
Portugal
Facility Name
Research Site
City
Lisboa
Country
Portugal
Facility Name
Research Site
City
Porto
Country
Portugal
Facility Name
Research Site
City
Vila Nova de Gaia
Country
Portugal
Facility Name
Research Site
City
Singapore
Country
Singapore
Facility Name
Research Site
City
A Coruña
Country
Spain
Facility Name
Research Site
City
Alicante
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Málaga
Country
Spain
Facility Name
Research Site
City
Zaragoza
Country
Spain
Facility Name
Research Site
City
Chiang Mai
Country
Thailand
Facility Name
Research Site
City
Ankara
Country
Turkey
Facility Name
Research Site
City
Istanbul
Country
Turkey
Facility Name
Research Site
City
Izmir
Country
Turkey
Facility Name
Research Site
City
Hanoi city
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh city
Country
Vietnam
12. IPD Sharing Statement
Citations:
PubMed Identifier
33075149
Citation
Lombard A, Mistry H, Aarons L, Ogungbenro K. Dose individualisation in oncology using chemotherapy-induced neutropenia: Example of docetaxel in non-small cell lung cancer patients. Br J Clin Pharmacol. 2021 Apr;87(4):2053-2063. doi: 10.1111/bcp.14614. Epub 2020 Dec 19.
Results Reference
derived
PubMed Identifier
25881079
Citation
Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer. 2015 Mar 23;15:171. doi: 10.1186/s12885-015-1146-8.
Results Reference
derived
PubMed Identifier
25057173
Citation
Heymach JV, Lockwood SJ, Herbst RS, Johnson BE, Ryan AJ. EGFR biomarkers predict benefit from vandetanib in combination with docetaxel in a randomized phase III study of second-line treatment of patients with advanced non-small cell lung cancer. Ann Oncol. 2014 Oct;25(10):1941-1948. doi: 10.1093/annonc/mdu269. Epub 2014 Jul 23.
Results Reference
derived
PubMed Identifier
20570559
Citation
Herbst RS, Sun Y, Eberhardt WE, Germonpre P, Saijo N, Zhou C, Wang J, Li L, Kabbinavar F, Ichinose Y, Qin S, Zhang L, Biesma B, Heymach JV, Langmuir P, Kennedy SJ, Tada H, Johnson BE. Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial. Lancet Oncol. 2010 Jul;11(7):619-26. doi: 10.1016/S1470-2045(10)70132-7.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=340&filename=CSR-D4200C00032.pdf
Description
CSR-D4200C00032.pdf
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=340&filename=vandetanib_Study_32_ZODIAC_CSP_Redacted.pdf
Description
CSP Redacted
Learn more about this trial
ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer
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