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← Malignant Head and Neck Neoplasm

NCT00248560 · STUDY IN CONTEXT

Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, 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. 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 v1.0) 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

→

secondary · POSTED

Response duration in months

Only those patients that have a recorded CR or PR

→

secondary · POSTED

Overall Survival using the Kaplan-Meier method

Source null

→

secondary · POSTED

Toxicity as the total number of participants with a given grade 3 and/or grade 4 adverse event

Source null

→

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
NCT00248560
trial label
Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, 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.
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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00248560
    outcome key
    om-0000
    source section id
    NCT00248560-om-0000
    source outcome index
    0
    endpoint
    Response (Complete Response [CR] + Partial Response [PR])
    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
    every 8 weeks for approximately 8 - 48 weeks
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00248560
    outcome key
    om-0001
    source section id
    NCT00248560-om-0001
    source outcome index
    1
    endpoint
    Response Duration
    endpoint definition
    Response duration in months
    time origin
    Every 8 weeks
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Only those patients that have a recorded CR or PR
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00248560
    outcome key
    om-0002
    source section id
    NCT00248560-om-0002
    source outcome index
    2
    endpoint
    Survival
    endpoint definition
    Overall Survival using the Kaplan-Meier method
    time origin
    Every 8 weeks
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00248560
    outcome key
    om-0003
    source section id
    NCT00248560-om-0003
    source outcome index
    3
    endpoint
    Toxicity as Measured by Number and Grade of Adverse Events
    endpoint definition
    Toxicity as the total number of participants with a given grade 3 and/or grade 4 adverse event
    time origin
    Every 2 weeks
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00248560
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Gemcitabine, Docetaxel
    regimen
    Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
    analyzed count
    36
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00248560-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00248560
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Gemcitabine, Docetaxel
    regimen
    Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine. docetaxel: Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine. Gemcitabine: Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00248560-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00248560
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Gemcitabine, Docetaxel
    regimen
    Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
    analyzed count
    36
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00248560-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00248560
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Gemcitabine, Docetaxel
    regimen
    Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
    analyzed count
    36
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00248560-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-head-and-neck-neoplasm
    nct id
    NCT00248560
    harm key
    EG000
    source section id
    NCT00248560-ae
    event group key
    EG000
    event group label
    Gemcitabine, Docetaxel
    serious affected
    25
    serious at risk
    36
    other affected
    33
    other at risk
    36
    frequency threshold
    5
    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