Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck

Draft scope assessment: unclear. Attached because the study's own record describes metastatic 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

Overall Survival

Source null

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secondary · POSTED

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Source null

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secondary · POSTED

Disease Control Rate

Source null

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secondary · POSTED

Progression-free Survival

Source null

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secondary · POSTED

ADVERSE EVENTS (AE) AND SERIOUS ADVERSE EVENTS (SAE) Adverse Events (AEs) will use the descriptions and grading scales found in the NCI CTCAE v3.0

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-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id: NCT01044433
trial label: Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck
applicability: unclear
applicability note: Attached because the study's own record describes metastatic 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: 5
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01044433
outcome key
om-0000
source section id
NCT01044433-om-0000
source outcome index
0
endpoint
Overall Survival
endpoint definition
Overall Survival
time origin
5 years
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-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01044433
outcome key
om-0001
source section id
NCT01044433-om-0001
source outcome index
1
endpoint
Response Rate
endpoint definition
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
time origin
5 years
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-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01044433
outcome key
om-0002
source section id
NCT01044433-om-0002
source outcome index
2
endpoint
Disease Control Rate
endpoint definition
Disease Control Rate
time origin
5 years
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-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01044433
outcome key
om-0003
source section id
NCT01044433-om-0003
source outcome index
3
endpoint
Progression-free Survival
endpoint definition
Progression-free Survival
time origin
5 years
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-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01044433
outcome key
om-0004
source section id
NCT01044433-om-0004
source outcome index
4
endpoint
Number of Participants With Adverse Events and Serious Adverse Events
endpoint definition
ADVERSE EVENTS (AE) AND SERIOUS ADVERSE EVENTS (SAE) Adverse Events (AEs) will use the descriptions and grading scales found in the NCI CTCAE v3.0
time origin
5 years
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-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01044433
outcome key
om-0000
arm key
OG000
arm label
Lapatinib Ditosylate and Capecitabine
regimen
Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
analyzed count
44
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01044433-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01044433
outcome key
om-0001
arm key
OG000
arm label
Arm I
regimen
Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
analyzed count
44
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01044433-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01044433
outcome key
om-0002
arm key
OG000
arm label
Arm I
regimen
Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
analyzed count
44
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01044433-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01044433
outcome key
om-0003
arm key
OG000
arm label
Arm I
regimen
Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
analyzed count
44
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01044433-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01044433
outcome key
om-0004
arm key
OG000
arm label
Arm I
regimen
Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14. lapatinib ditosylate: Given orally capecitabine: Given orally
analyzed count
44
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01044433-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-metastatic-squamous-neck-cancer-with-occult-primary-metastatic-305bfb14
nct id
NCT01044433
harm key
EG000
source section id
NCT01044433-ae
event group key
EG000
event group label
Lapatinib Ditosylate and Capecitabine
serious affected
44
serious at risk
44
other affected
0
other at risk
44
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