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NCT01064479 · STUDY IN CONTEXT

Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

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

Kaplan-Meier methods will be used to summarize PFS. In the primary analysis, differences in PFS in Arm A versus Arm B will be tested using a stratified log-rank test with a two-sided alpha of 0.10. Hazard ratios for PFS will be presented using point estimates and 95% confidence intervals.

Source null

→

secondary · POSTED

Kaplan-Meier methods will be used to summarize OS. Hazard ratios for OS will be presented using point estimates and 95% confidence intervals.

Source null

→

secondary · POSTED

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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

Source null

→

secondary · POSTED

Complete Response (CR) + Partial Response (PR) + Stable disease

Source null

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secondary · POSTED

Participants with a Rash of at least grade 2 within cycle 1.

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-oropharyngeal-cancer-recurrent-f3bd66bf
nct id
NCT01064479
trial label
Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
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
5
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    outcome key
    om-0000
    source section id
    NCT01064479-om-0000
    source outcome index
    0
    endpoint
    Progression Free Survival (PFS)
    endpoint definition
    Kaplan-Meier methods will be used to summarize PFS. In the primary analysis, differences in PFS in Arm A versus Arm B will be tested using a stratified log-rank test with a two-sided alpha of 0.10. Hazard ratios for PFS will be presented using point estimates and 95% confidence intervals.
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    outcome key
    om-0001
    source section id
    NCT01064479-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    Kaplan-Meier methods will be used to summarize OS. Hazard ratios for OS will be presented using point estimates and 95% confidence intervals.
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    outcome key
    om-0002
    source section id
    NCT01064479-om-0002
    source outcome index
    2
    endpoint
    Number of Participants With Tumor Response (Complete Response [CR] + Partial Response [PR])
    endpoint definition
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    outcome key
    om-0003
    source section id
    NCT01064479-om-0003
    source outcome index
    3
    endpoint
    Disease Control (CR + PR + Stable Disease [SD])
    endpoint definition
    Complete Response (CR) + Partial Response (PR) + Stable disease
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    outcome key
    om-0004
    source section id
    NCT01064479-om-0004
    source outcome index
    4
    endpoint
    Rash Rates
    endpoint definition
    Participants with a Rash of at least grade 2 within cycle 1.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
    regimen
    Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
    analyzed count
    60
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01064479-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm B (Combination Chemotherapy and Placebo)
    regimen
    Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
    analyzed count
    59
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01064479-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
    regimen
    Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
    analyzed count
    60
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01064479-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm B (Combination Chemotherapy and Placebo)
    regimen
    Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
    analyzed count
    59
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01064479-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
    regimen
    Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
    analyzed count
    60
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01064479-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm B (Combination Chemotherapy and Placebo)
    regimen
    Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
    analyzed count
    59
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01064479-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
    regimen
    Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
    analyzed count
    60
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01064479-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Arm B (Combination Chemotherapy and Placebo)
    regimen
    Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
    analyzed count
    59
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01064479-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
    regimen
    Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
    analyzed count
    60
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01064479-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Arm B (Combination Chemotherapy and Placebo)
    regimen
    Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
    analyzed count
    59
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01064479-om-0004#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    harm key
    EG000
    source section id
    NCT01064479-ae
    event group key
    EG000
    event group label
    Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
    serious affected
    21
    serious at risk
    60
    other affected
    56
    other at risk
    60
    frequency threshold
    5
    collection period
    From the first dose through 30 days after the last does of study medication, up to 5 years
    event definition
    MedDRA v12
    undenominated 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-oropharyngeal-cancer-recurrent-f3bd66bf
    nct id
    NCT01064479
    harm key
    EG001
    source section id
    NCT01064479-ae
    event group key
    EG001
    event group label
    Arm B (Combination Chemotherapy and Placebo)
    serious affected
    46
    serious at risk
    59
    other affected
    55
    other at risk
    59
    frequency threshold
    5
    collection period
    From the first dose through 30 days after the last does of study medication, up to 5 years
    event definition
    MedDRA v12
    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