Trial · NCT00459043
Docetaxel in Combination With Zactima (ZD6474) in Patients With Locally Advanced Squamous Cell Carcinoma of the the Head and Neck
NCT00459043, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2013-07-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Docetaxel in Combination With Zactima (ZD6474) in Patients With Locally Advanced Squamous Cell Carcinoma of the the Head and Neck. Trials, record NCT00459043. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00459043
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Docetaxel in Combination With Zactima (ZD6474) in Patients With Locally Advanced Squamous Cell Carcinoma of the the Head and Neck
- NCT number
- NCT00459043
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Interventions
- ZD6474, Docetaxel
- First posted
- 2007-04-11
- Last updated
- 2013-07-03
- Results first posted
- 2013-07-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Partial Response Rate in Both Groups of Patients. | 3 years | Objective tumor response was evaluated radiogically using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. For target lesions: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) \>= 30% decrease in the sum of the longest diamter of target lesions; Overall Response (OR) = CR+PR |
| Secondary | Progression Free Survival | 3 years | Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sumof the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions |
| Secondary | Overall Survival | 3 years |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Partial Response Rate in Both Groups of Patients. | 3 years | 29 patients were analyzable | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival | 3 years | weeks | MEDIAN | |
| SECONDARY | Overall Survival | 3 years | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Partial Response Rate in Both Groups of Patients. | 1Docetaxel Single Agent | 7 | 95% Confidence Interval 0.2 to 33.8 | percentage of participants | |
| Partial Response Rate in Both Groups of Patients. | 2 Combination Docetaxel and ZD6474 | 13 | 95% Confidence Interval 1.6 to 40.4 | percentage of participants | |
| Progression Free Survival | 1Docetaxel Single Agent | 3.21 | 95% Confidence Interval 3.0 to 22.0 | weeks | |
| Progression Free Survival | 2 Combination Docetaxel and ZD6474 | 9 | 95% Confidence Interval 5.86 to 18.1 | weeks | |
| Overall Survival | 1Docetaxel Single Agent | 26.8 | 95% Confidence Interval 17.7 to 100.7 | weeks | |
| Overall Survival | 2 Combination Docetaxel and ZD6474 | 24.1 | 95% Confidence Interval 16.4 to 171.1 | weeks |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1Docetaxel Single Agent | 15 | |
| Overall Study | STARTED | 2 Combination Docetaxel and ZD6474 | 15 | |
| Overall Study | COMPLETED | 1Docetaxel Single Agent | 14 | |
| Overall Study | COMPLETED | 2 Combination Docetaxel and ZD6474 | 15 | |
| Overall Study | NOT COMPLETED | 1Docetaxel Single Agent | 1 | |
| Overall Study | NOT COMPLETED | 2 Combination Docetaxel and ZD6474 | 0 |
Source ClinicalTrials.gov
Adverse events28
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 | Neutrophils | Blood and lymphatic system disorders | 1Docetaxel Single Agent | 11 | 14 | |
| other | Neutrophils | Blood and lymphatic system disorders | 2 Combination Docetaxel and ZD6474 | 10 | 15 | |
| other | Dysphagia | Gastrointestinal disorders | 1Docetaxel Single Agent | 8 | 14 | |
| other | Dysphagia | Gastrointestinal disorders | 2 Combination Docetaxel and ZD6474 | 8 | 15 | |
| other | Constipation | Gastrointestinal disorders | 1Docetaxel Single Agent | 6 | 14 | |
| other | Constipation | Gastrointestinal disorders | 2 Combination Docetaxel and ZD6474 | 7 | 15 | |
| other | Diarrhea | Gastrointestinal disorders | 1Docetaxel Single Agent | 2 | 14 | |
| other | Diarrhea | Gastrointestinal disorders | 2 Combination Docetaxel and ZD6474 | 8 | 15 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | 1Docetaxel Single Agent | 5 | 14 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | 2 Combination Docetaxel and ZD6474 | 7 | 15 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1Docetaxel Single Agent | ||
| Total, all-cause mortality | 2 Combination Docetaxel and ZD6474 | ||
| Total, other adverse events | 1Docetaxel Single Agent | 14 | 14 |
| Total, other adverse events | 2 Combination Docetaxel and ZD6474 | 15 | 15 |
| Total, serious adverse events | 1Docetaxel Single Agent | 1 | 14 |
| Total, serious adverse events | 2 Combination Docetaxel and ZD6474 | 1 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 1Docetaxel Single Agent vs 2 Combination Docetaxel and ZD6474: serious adverse events |
Source 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/NCT00459043
GET https://conductscience.org/api/trials/v1/NCT00459043/events?page=2