Trial · NCT00312377
ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer
NCT00312377, Phase 3, Completed, Genzyme, a Sanofi Company; results first posted 2011-05-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer. Trials, record NCT00312377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00312377
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer
- NCT number
- NCT00312377
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,690 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Non-small Cell Lung Cancer, Lung Cancer
- Interventions
- Docetaxel, Vandetanib
- First posted
- 2006-04-10
- Last updated
- 2016-09-30
- Other registries' IDs
- eudract:2005-004749-32
- Results first posted
- 2011-05-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) in the Overall Population | 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 | 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. |
| Primary | Progression-Free Survival (PFS) in the Female Population | 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 | 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 | Overall Survival (OS) in the Overall Population | Time to death in months | 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). |
| Secondary | Overall Survival (OS) in the Female Population | Time to death in months | 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). |
| Secondary | Objective Response Rate (ORR) | 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 | 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. |
| Secondary | Disease Control Rate (DCR) | RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression | 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. |
| Secondary | Duration of Response (DoR) | RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression | 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) |
| Secondary | Time to Deterioration of Disease-related Symptoms (TDS) by Functional Assessment of Cancer Therapy - Lung (FACT-L) Lung Cancer Subscale (LCS). | FACT-L questionnaires are to be administered every 3 weeks after randomisation | 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. |
| Secondary | Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Pulmonary Symptom Index (PSI) | FACT-L questionnaires are to be administered every 3 weeks after randomisation | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) in the Overall Population | 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 | Weeks | MEDIAN | |
| PRIMARY | Progression-Free Survival (PFS) in the Female Population | 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 | Weeks | MEDIAN | |
| SECONDARY | Overall Survival (OS) in the Overall Population | Time to death in months | Months | MEDIAN | |
| SECONDARY | Overall Survival (OS) in the Female Population | Time to death in months | Months | MEDIAN | |
| SECONDARY | Objective Response Rate (ORR) | 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 | Participants | NUMBER | |
| SECONDARY | Disease Control Rate (DCR) | RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression | Participants | NUMBER | |
| SECONDARY | Duration of Response (DoR) | RECIST tumour assessments carried out every 6 weeks from randomisation until objective progression | Weeks | MEDIAN | |
| SECONDARY | Time to Deterioration of Disease-related Symptoms (TDS) by Functional Assessment of Cancer Therapy - Lung (FACT-L) Lung Cancer Subscale (LCS). | FACT-L questionnaires are to be administered every 3 weeks after randomisation | Weeks | MEDIAN | |
| SECONDARY | Time to Deterioration of Disease-related Symptoms (TDS) by FACT-L Pulmonary Symptom Index (PSI) | FACT-L questionnaires are to be administered every 3 weeks after randomisation | Weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) in the Overall Population | Vandetanib 100 mg Plus Docetaxel | 17.3 | 95% Confidence Interval 15 to 18 | Weeks | |
| Progression-Free Survival (PFS) in the Overall Population | Placebo Plus Docetaxel | 14 | 95% Confidence Interval 12.7 to 16.9 | Weeks | |
| Progression-Free Survival (PFS) in the Female Population | Vandetanib 100 mg Plus Docetaxel | 20.1 | 95% Confidence Interval 17.9 to 23.9 | Weeks | |
| Progression-Free Survival (PFS) in the Female Population | Placebo Plus Docetaxel | 18.3 | 95% Confidence Interval 15 to 22.1 | Weeks | |
| Overall Survival (OS) in the Overall Population | Vandetanib 100 mg Plus Docetaxel | 10.6 | 95% Confidence Interval 9.6 to 11.5 | Months | |
| Overall Survival (OS) in the Overall Population | Placebo Plus Docetaxel | 10 | 95% Confidence Interval 9.2 to 10.8 | Months | |
| Overall Survival (OS) in the Female Population | Vandetanib 100 mg Plus Docetaxel | 12.7 | 95% Confidence Interval 10.5 to 17.1 | Months | |
| Overall Survival (OS) in the Female Population | Placebo Plus Docetaxel | 14.2 | 95% Confidence Interval 10.8 to 16.2 | Months | |
| Objective Response Rate (ORR) | Vandetanib 100 mg Plus Docetaxel | 120 | Participants | ||
| Objective Response Rate (ORR) | Placebo Plus Docetaxel | 71 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vandetanib 100 mg Plus Docetaxel | 694 | |
| Overall Study | STARTED | Placebo Plus Docetaxel | 697 | |
| Overall Study | COMPLETED | Vandetanib 100 mg Plus Docetaxel | 50 | |
| Overall Study | COMPLETED | Placebo Plus Docetaxel | 29 | |
| Overall Study | NOT COMPLETED | Vandetanib 100 mg Plus Docetaxel | 644 | |
| Overall Study | NOT COMPLETED | Placebo Plus Docetaxel | 668 |
Source ClinicalTrials.gov
Adverse events590
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Vandetanib 100 mg Plus Docetaxel | 212 | 694 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo Plus Docetaxel | 174 | 697 | |
| other | Leukopenia | Blood and lymphatic system disorders | Vandetanib 100 mg Plus Docetaxel | 125 | 694 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo Plus Docetaxel | 106 | 697 | |
| other | Anaemia | Blood and lymphatic system disorders | Vandetanib 100 mg Plus Docetaxel | 68 | 694 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Plus Docetaxel | 98 | 697 | |
| other | Diarrhoea | Gastrointestinal disorders | Vandetanib 100 mg Plus Docetaxel | 284 | 694 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Plus Docetaxel | 218 | 697 | |
| other | Nausea | Gastrointestinal disorders | Vandetanib 100 mg Plus Docetaxel | 158 | 694 | |
| other | Nausea | Gastrointestinal disorders | Placebo Plus Docetaxel | 221 | 697 |
1 to 10 of 590Source ClinicalTrials.gov
See all 590 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vandetanib 100 mg Plus Docetaxel | ||
| Total, all-cause mortality | Placebo Plus Docetaxel | ||
| Total, other adverse events | Vandetanib 100 mg Plus Docetaxel | 637 | 694 |
| Total, other adverse events | Placebo Plus Docetaxel | 630 | 697 |
| Total, serious adverse events | Vandetanib 100 mg Plus Docetaxel | 263 | 694 |
| Total, serious adverse events | Placebo Plus Docetaxel | 232 | 697 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vandetanib 100 mg Plus Docetaxel vs Placebo Plus Docetaxel: Objective Response Rate (ORR) | Trial comparisons |
| Vandetanib 100 mg Plus Docetaxel vs Placebo Plus Docetaxel: Disease Control Rate (DCR) | Trial comparisons |
| Vandetanib 100 mg Plus Docetaxel vs Placebo Plus Docetaxel: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00312377
GET https://conductscience.org/api/trials/v1/NCT00312377/events?page=2