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NCT00103259 · STUDY IN CONTEXT

Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic 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

Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.

61 eligible and treated patients were included in the analysis

→

secondary · POSTED

Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.

10 eligible and treated patients who progressed on bortezomib and crossed over to bortezomib and irinotecan arm were included in the analysis

→

secondary · POSTED

Progression-free survival was defined as time from registration to step 1 to disease recurrence or death from any cause, whichever occurred first. Disease progression was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions.

61 eligible and treated patients were included in the analysis

→

secondary · POSTED

Overall survival was defined as time from registration on step 1 to death from any cause. It was evaluated in all 61 eligible and treated patients.

61 eligible and treated patients were included in the analysis

→

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-hypopharyngeal-cancer-recurrent-58d713f9
nct id
NCT00103259
trial label
Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic 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
4
harms Count
3
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer-recurrent-58d713f9
    nct id
    NCT00103259
    outcome key
    om-0000
    source section id
    NCT00103259-om-0000
    source outcome index
    0
    endpoint
    Response Rate on Step 1
    endpoint definition
    Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.
    time origin
    Tumor response was assessed every 2 cycles until progression or intolerable toxicity with maximum of 3 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    61 eligible and treated patients were included in the analysis
    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-hypopharyngeal-cancer-recurrent-58d713f9
    nct id
    NCT00103259
    outcome key
    om-0001
    source section id
    NCT00103259-om-0001
    source outcome index
    1
    endpoint
    Response Rate on Step 2
    endpoint definition
    Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.
    time origin
    Tumor response was assessed after every 2 cycles until progression or intolerable toxicity with maximum of 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    10 eligible and treated patients who progressed on bortezomib and crossed over to bortezomib and irinotecan arm were included in the analysis
    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-hypopharyngeal-cancer-recurrent-58d713f9
    nct id
    NCT00103259
    outcome key
    om-0002
    source section id
    NCT00103259-om-0002
    source outcome index
    2
    endpoint
    Progression-free Survival on Step 1
    endpoint definition
    Progression-free survival was defined as time from registration to step 1 to disease recurrence or death from any cause, whichever occurred first. Disease progression was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions.
    time origin
    Every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entry
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    61 eligible and treated patients were included in the analysis
    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-hypopharyngeal-cancer-recurrent-58d713f9
    nct id
    NCT00103259
    outcome key
    om-0003
    source section id
    NCT00103259-om-0003
    source outcome index
    3
    endpoint
    Overall Survival on Step 1
    endpoint definition
    Overall survival was defined as time from registration on step 1 to death from any cause. It was evaluated in all 61 eligible and treated patients.
    time origin
    Survival was assessed every 3 month within 2 years and every 6 months betwen 2 and 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    61 eligible and treated patients were included in the analysis
    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-hypopharyngeal-cancer-recurrent-58d713f9
    nct id
    NCT00103259
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I (Bortezomib+Irinotecan)
    regimen
    Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00103259-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer-recurrent-58d713f9
    nct id
    NCT00103259
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm II (Bortezomib)
    regimen
    Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
    analyzed count
    38
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00103259-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer-recurrent-58d713f9
    nct id
    NCT00103259
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Cross-over From Bortezomib to Combined Arm
    regimen
    Patients progressed on bortezomib in step 1 crossed over to the combination arm. Response rate is evaluated in these patients.
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00103259-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer-recurrent-58d713f9
    nct id
    NCT00103259
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm I (Bortezomib+Irinotecan)
    regimen
    Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00103259-om-0002#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer-recurrent-58d713f9
    nct id
    NCT00103259
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm II (Bortezomib)
    regimen
    Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
    analyzed count
    38
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00103259-om-0002#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer-recurrent-58d713f9
    nct id
    NCT00103259
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm I (Bortezomib+Irinotecan)
    regimen
    Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00103259-om-0003#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer-recurrent-58d713f9
    nct id
    NCT00103259
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Arm II (Bortezomib)
    regimen
    Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
    analyzed count
    38
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00103259-om-0003#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hypopharyngeal-cancer-recurrent-58d713f9
    nct id
    NCT00103259
    harm key
    EG000
    source section id
    NCT00103259-ae
    event group key
    EG000
    event group label
    Arm I (Bortezomib+Irinotecan)
    serious affected
    17
    serious at risk
    23
    other affected
    23
    other at risk
    23
    frequency threshold
    5
    collection period
    Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
    event definition
    All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
    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-hypopharyngeal-cancer-recurrent-58d713f9
    nct id
    NCT00103259
    harm key
    EG001
    source section id
    NCT00103259-ae
    event group key
    EG001
    event group label
    Arm II (Bortezomib)
    serious affected
    21
    serious at risk
    41
    other affected
    40
    other at risk
    41
    frequency threshold
    5
    collection period
    Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
    event definition
    All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
    undenominated 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-hypopharyngeal-cancer-recurrent-58d713f9
    nct id
    NCT00103259
    harm key
    EG002
    source section id
    NCT00103259-ae
    event group key
    EG002
    event group label
    Cross-over Patients
    serious affected
    6
    serious at risk
    11
    other affected
    11
    other at risk
    11
    frequency threshold
    5
    collection period
    Toxicity is assessed at the end of each cycle (1 cycle = 21 days) and at the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
    event definition
    All patients who received protocol therapy were evaluated for toxicity, regardless of eligibility
    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