NCT00970502 · STUDY IN CONTEXT

Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

Number of participants with acute and late toxicity

Erlotinib and celecoxib were administered orally

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secondary · POSTED

Response to Concurrent Erlotinib, Celecoxib, and Reirradiation according to Response Evaluation Criteria in Solid Tumors - Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Source null

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secondary · POSTED

Patients with locoregional and/or distant progression

Source null

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secondary · POSTED

At a median follow-up of 11 months, the 1 year locoregional control, progression-free survival, and overall survival rates.

Source null

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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-laryngeal-cancer-recurrent-46e24458
nct id: NCT00970502
trial label: Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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-laryngeal-cancer-recurrent-46e24458
nct id
NCT00970502
outcome key
om-0000
source section id
NCT00970502-om-0000
source outcome index
0
endpoint
Toxicity
endpoint definition
Number of participants with acute and late toxicity
time origin
30 DAYS
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Erlotinib and celecoxib were administered orally
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-laryngeal-cancer-recurrent-46e24458
nct id
NCT00970502
outcome key
om-0001
source section id
NCT00970502-om-0001
source outcome index
1
endpoint
Clinical Response
endpoint definition
Response to Concurrent Erlotinib, Celecoxib, and Reirradiation according to Response Evaluation Criteria in Solid Tumors - Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
time origin
20 months
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-laryngeal-cancer-recurrent-46e24458
nct id
NCT00970502
outcome key
om-0002
source section id
NCT00970502-om-0002
source outcome index
2
endpoint
Locoregional Progression
endpoint definition
Patients with locoregional and/or distant progression
time origin
20 months
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-laryngeal-cancer-recurrent-46e24458
nct id
NCT00970502
outcome key
om-0003
source section id
NCT00970502-om-0003
source outcome index
3
endpoint
Locoregional Control, Progression-free Survival, Overall Survival and Late Toxicity
endpoint definition
At a median follow-up of 11 months, the 1 year locoregional control, progression-free survival, and overall survival rates.
time origin
1 year
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

arms

release id
clinical-indications-draft-1
disease state id
ds-laryngeal-cancer-recurrent-46e24458
nct id
NCT00970502
outcome key
om-0000
arm key
OG000
arm label
Celecoxib 200mg
regimen
Dose Level 1: Patients administered 150mg Erlotinib daily and 200mg Celecoxib twice daily
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00970502-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-laryngeal-cancer-recurrent-46e24458
nct id
NCT00970502
outcome key
om-0000
arm key
OG001
arm label
Celecoxib 400mg
regimen
Dose Level 2: Patients administered 150mg Erlotinib daily and 400mg Celecoxib twice daily
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00970502-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-laryngeal-cancer-recurrent-46e24458
nct id
NCT00970502
outcome key
om-0000
arm key
OG002
arm label
Celecoxib 600mg
regimen
Dose Level 3: Patients administered 150mg Erlotinib daily and 600mg Celecoxib twice daily
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00970502-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-laryngeal-cancer-recurrent-46e24458
nct id
NCT00970502
outcome key
om-0001
arm key
OG000
arm label
Erlotinib + Celecoxib
regimen
erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00970502-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-laryngeal-cancer-recurrent-46e24458
nct id
NCT00970502
outcome key
om-0002
arm key
OG000
arm label
Erlotinib + Celecoxib
regimen
erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00970502-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-laryngeal-cancer-recurrent-46e24458
nct id
NCT00970502
outcome key
om-0003
arm key
OG000
arm label
Erlotinib + Celecoxib
regimen
Recommended dose of celecoxib was 400mg
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00970502-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-laryngeal-cancer-recurrent-46e24458
nct id
NCT00970502
harm key
EG000
source section id
NCT00970502-ae
event group key
EG000
event group label
Erlotinib + Celecoxib
serious affected
14
serious at risk
14
other affected
14
other at risk
14
frequency threshold
0
collection period
Source null
event definition
Source null
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