Trial · NCT00088907

Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer

NCT00088907, Phase 3, Terminated, National Cancer Institute (NCI); results first posted 2015-05-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer. Trials, record NCT00088907. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00088907

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer
NCT number: NCT00088907
Status: Terminated
Phases: Phase 3
Enrollment: 270 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Recurrent Head and Neck Cancer, Metastatic Head and Neck Cancer
Interventions: docetaxel, placebo, gefitinib
First posted: 2004-08-05
Last updated: 2015-05-06
Results first posted: 2015-05-06

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival	assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.	Overall survival is defined as time from registration to death from any cause. All eligible and treated patients were included in the analysis.
Secondary	Time to Progression	assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.	Time to progression is defined as time from registration to disease progression. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions . Tumor measurements may be made using physical examination, CT scans or MRI scans. While on protocol treatment, tumor measurement by physical examination to be done every 4 weeks, and tumor measurement by CT/MRI scans to be done every 8 weeks (every 2 treatment cycles). All eligible and treated patients were included in the analysis.
Secondary	Overall Response Rate	assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.	Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Complete response (CR) was defined disappearance of all tumor lesions. Partial response (PR) was defined as as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. Overall response rate= CR+PR. Tumor measurements may be made using physical examination, CT scans or MRI scans. While on protocol treatment, tumor measurement by physical examination to be done every 4 weeks, and tumor measurement by CT/MRI scans to be done every 8 weeks (every 2 treatment cycles). All eligible and treated patients were included in the analysis.

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	Overall Survival	assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.	eligible and treated patients	months	MEDIAN
SECONDARY	Time to Progression	assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.	eligible and treated patients	months	MEDIAN
SECONDARY	Overall Response Rate	assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.	eligible and treated patients	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Survival	Arm I (Docetaxel and Placebo)	5.98	95% Confidence Interval 4.93 to 7.43	months
Overall Survival	Arm II (Docetaxel and Gefitinib)	7.33	95% Confidence Interval 5.75 to 8.44	months
Time to Progression	Arm I (Docetaxel and Placebo)	2.14	95% Confidence Interval 1.97 to 3.48	months
Time to Progression	Arm II (Docetaxel and Gefitinib)	3.55	95% Confidence Interval 2.76 to 3.75	months
Overall Response Rate	Arm I (Docetaxel and Placebo)	4.3	95% Confidence Interval 1.4 to 9.7	percentage of participants
Overall Response Rate	Arm II (Docetaxel and Gefitinib)	9.8	95% Confidence Interval 5.2 to 16.6	percentage of participants

Source ClinicalTrials.gov

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Randomized Study (Step 1)	STARTED	Arm I (Docetaxel and Placebo)	136
Randomized Study (Step 1)	STARTED	Arm II (Docetaxel and Gefitinib)	134
Randomized Study (Step 1)	Treated	Arm I (Docetaxel and Placebo)	129
Randomized Study (Step 1)	Treated	Arm II (Docetaxel and Gefitinib)	124
Randomized Study (Step 1)	Eligible	Arm I (Docetaxel and Placebo)	117
Randomized Study (Step 1)	Eligible	Arm II (Docetaxel and Gefitinib)	122
Randomized Study (Step 1)	Eligible and Treated	Arm I (Docetaxel and Placebo)	117
Randomized Study (Step 1)	Eligible and Treated	Arm II (Docetaxel and Gefitinib)	122
Randomized Study (Step 1)	COMPLETED	Arm I (Docetaxel and Placebo)	0
Randomized Study (Step 1)	COMPLETED	Arm II (Docetaxel and Gefitinib)	0

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events261

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
other	Anemia	Blood and lymphatic system disorders	Step 1: Docetaxel+Placebo	10	129
other	Anemia	Blood and lymphatic system disorders	Step 1: Docetaxel+ZD1839	16	124
other	Anemia	Blood and lymphatic system disorders	Step 2: ZD1839	0	19
other	White blood cell decreased	Investigations	Step 1: Docetaxel+Placebo	4	129
other	White blood cell decreased	Investigations	Step 1: Docetaxel+ZD1839	7	124
other	White blood cell decreased	Investigations	Step 2: ZD1839	0	19
other	Fatigue	General disorders	Step 1: Docetaxel+Placebo	11	129
other	Fatigue	General disorders	Step 1: Docetaxel+ZD1839	14	124
other	Fatigue	General disorders	Step 2: ZD1839	1	19
other	Dry skin	Skin and subcutaneous tissue disorders	Step 1: Docetaxel+Placebo	0	129

1 to 10 of 261Source ClinicalTrials.gov

See all 261 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Step 1: Docetaxel+Placebo
Total, all-cause mortality	Step 1: Docetaxel+ZD1839
Total, all-cause mortality	Step 2: ZD1839
Total, other adverse events	Step 1: Docetaxel+Placebo	16	129
Total, other adverse events	Step 1: Docetaxel+ZD1839	25	124
Total, other adverse events	Step 2: ZD1839	2	19
Total, serious adverse events	Step 1: Docetaxel+Placebo	64	129
Total, serious adverse events	Step 1: Docetaxel+ZD1839	61	124
Total, serious adverse events	Step 2: ZD1839	2	19

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23460714	RESULT

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA021115	Eastern Cooperative Oncology Group Operations Office	COMIS, ROBERT L	FRONTIER SCI & TECHNOLOGY RSCH FDN, INC	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00088907

GET https://conductscience.org/api/trials/v1/NCT00088907/events?page=2

API reference For AI assistants