Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.

Source null

→

secondary · POSTED

Overall survival is defined as the length of time from start of treatment to death from any cause. Estimated using the Kaplan-Meier method.

16 patients of the 25 were eligible for response assessment.

→

secondary · POSTED

PFS is defined as the duration of time from start of treatment to time of progression, death, or completion of the 1-year follow-up, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions.

16 of 25 patients were evaluable for response.

→

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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id: NCT01267240
trial label: Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 3
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id
NCT01267240
outcome key
om-0000
source section id
NCT01267240-om-0000
source outcome index
0
endpoint
Response Rate According to Response Evaluation Criteria in Solid Tumors
endpoint definition
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR.
time origin
Up to 1 year
analysis role
primary
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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id
NCT01267240
outcome key
om-0001
source section id
NCT01267240-om-0001
source outcome index
1
endpoint
Survival
endpoint definition
Overall survival is defined as the length of time from start of treatment to death from any cause. Estimated using the Kaplan-Meier method.
time origin
Up to 1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
16 patients of the 25 were eligible for response assessment.
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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id
NCT01267240
outcome key
om-0002
source section id
NCT01267240-om-0002
source outcome index
2
endpoint
Progression-free Survival
endpoint definition
PFS is defined as the duration of time from start of treatment to time of progression, death, or completion of the 1-year follow-up, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions.
time origin
From time of treatment initiation to disease progression, death, or completion of the 1 year follow-up, whichever occurs first.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
16 of 25 patients were evaluable for response.
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-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id
NCT01267240
outcome key
om-0000
arm key
OG000
arm label
Arm I (Capecitabine, Vorinostat)
regimen
Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Vorinostat: Given PO
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01267240-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id
NCT01267240
outcome key
om-0001
arm key
OG000
arm label
Arm I (Capecitabine, Vorinostat)
regimen
Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Vorinostat: Given PO
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01267240-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id
NCT01267240
outcome key
om-0002
arm key
OG000
arm label
Arm I (Capecitabine, Vorinostat)
regimen
Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Vorinostat: Given PO
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01267240-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-lip-and-oral-cavity-squamous-cell-carcinoma-ajcc-v6-and-v7
nct id
NCT01267240
harm key
EG000
source section id
NCT01267240-ae
event group key
EG000
event group label
Arm I (Capecitabine, Vorinostat)
serious affected
7
serious at risk
25
other affected
25
other at risk
25
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