NCT00337129 · STUDY IN CONTEXT

S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.

Only eligible patients were included in the analysis

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secondary · POSTED

Progression-free survival was defined as the time from date of registration to the date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at date of last contact.

Source null

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secondary · POSTED

Overall survival was defined as the time from the date of registration to the date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Only eligible patients were included in the analysis.

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secondary · POSTED

The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.

All eligible patients who started protocol treatment are included in analysis of toxicity

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-malignant-head-and-neck-neoplasm
nct id: NCT00337129
trial label: S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00337129
outcome key
om-0000
source section id
NCT00337129-om-0000
source outcome index
0
endpoint
Response Probability (Confirmed Complete and Partial Responses)
endpoint definition
Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.
time origin
Every 6 weeks until progression of disease up to a maximum of 3 years after registration
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Only eligible patients were included in the analysis
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00337129
outcome key
om-0001
source section id
NCT00337129-om-0001
source outcome index
1
endpoint
Progression-Free Survival
endpoint definition
Progression-free survival was defined as the time from date of registration to the date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at date of last contact.
time origin
Every 6 weeks until progression of disease up to a maximum of 3 years after registration.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00337129
outcome key
om-0002
source section id
NCT00337129-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
Overall survival was defined as the time from the date of registration to the date of death due to any cause. Patients last known to be alive are censored at date of last contact.
time origin
Every 3 months for first year, then every six months thereafter up to a maximum of 3 years from registration.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Only eligible patients were included in the analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00337129
outcome key
om-0003
source section id
NCT00337129-om-0003
source outcome index
3
endpoint
Participants With a Given Type of AE
endpoint definition
The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.
time origin
Every 3 weeks while on protocol therapy, up to 3 years.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All eligible patients who started protocol treatment are included in analysis of toxicity
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00337129
outcome key
om-0000
arm key
OG000
arm label
Treatment (E7389 IV)
regimen
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00337129-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00337129
outcome key
om-0001
arm key
OG000
arm label
Treatment (E7389 IV)
regimen
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00337129-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00337129
outcome key
om-0002
arm key
OG000
arm label
Treatment (E7389 IV)
regimen
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00337129-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00337129
outcome key
om-0003
arm key
OG000
arm label
Treatment (E7389 IV)
regimen
Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
analyzed count
40
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00337129-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-malignant-head-and-neck-neoplasm
nct id
NCT00337129
harm key
EG000
source section id
NCT00337129-ae
event group key
EG000
event group label
Treatment (E7389 IV)
serious affected
5
serious at risk
40
other affected
36
other at risk
40
frequency threshold
5
collection period
Patients were assessed on Day 1 and Day 8 of every 21-day cycle of treatment.
event definition
This study utilized the CTCAE (NCI Common Toxicity Criteria for Adverse Events) version 3.0
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice