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NCT00084682 · STUDY IN CONTEXT

Depsipeptide in Unresectable 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 assessed every eight weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions as 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. Stable disease (SD) was defined as having no evidence of response (CR or PR) as best response to therapy, and no evidence of disease progression (appearance of new lesions or \>/= 30% increase in target lesions) at 8 weeks.

Source null

→

secondary · POSTED

Duration of Response

Data not collected. As the first stage goal of 8 patients with disease control was not achievable, further analysis was not done.

→

secondary · POSTED

All time to event endpoints will be evaluated using Kaplan Meier estimates and survival curves will be generated based on these estimates.

Data not collected. As the first stage goal of 8 patients with disease control was not achievable, further follow up was not done.

→

secondary · POSTED

All time to event endpoints will be evaluated using Kaplan Meier estimates and survival curves will be generated based on these estimates. One and two-year survival and median survival time (if attained) will be estimated and reported with 95% confidence limits. If the sample sizes are sufficient, subgroup analysis based on baseline factors will be performed using the log rank test to compare survival curves.

data not collected

→

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

FACT · Overall Survival

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-laryngeal-cancer-recurrent-46e24458
nct id
NCT00084682
qol key
qol-0003
source section id
NCT00084682-om-0003
source outcome index
3
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Overall Survival
measure definition
All time to event endpoints will be evaluated using Kaplan Meier estimates and survival curves will be generated based on these estimates. One and two-year survival and median survival time (if attained) will be estimated and reported with 95% confidence limits. If the sample sizes are sufficient, subgroup analysis based on baseline factors will be performed using the log rank test to compare survival curves.
time frame
Up to 2 years
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
data not collected
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-laryngeal-cancer-recurrent-46e24458
nct id
NCT00084682
trial label
Depsipeptide in Unresectable 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
1
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-recurrent-46e24458
    nct id
    NCT00084682
    outcome key
    om-0000
    source section id
    NCT00084682-om-0000
    source outcome index
    0
    endpoint
    Disease Control (i.e., Achievement of Complete Response, Partial Response, or Stable Disease)
    endpoint definition
    Tumor response was assessed every eight weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions as 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. Stable disease (SD) was defined as having no evidence of response (CR or PR) as best response to therapy, and no evidence of disease progression (appearance of new lesions or \>/= 30% increase in target lesions) at 8 weeks.
    time origin
    Up to 2 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-laryngeal-cancer-recurrent-46e24458
    nct id
    NCT00084682
    outcome key
    om-0001
    source section id
    NCT00084682-om-0001
    source outcome index
    1
    endpoint
    Duration of Response
    endpoint definition
    Duration of Response
    time origin
    Up to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data not collected. As the first stage goal of 8 patients with disease control was not achievable, further analysis was not done.
    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-laryngeal-cancer-recurrent-46e24458
    nct id
    NCT00084682
    outcome key
    om-0002
    source section id
    NCT00084682-om-0002
    source outcome index
    2
    endpoint
    Time to Progression
    endpoint definition
    All time to event endpoints will be evaluated using Kaplan Meier estimates and survival curves will be generated based on these estimates.
    time origin
    Up to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data not collected. As the first stage goal of 8 patients with disease control was not achievable, further follow up was not done.
    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-laryngeal-cancer-recurrent-46e24458
    nct id
    NCT00084682
    outcome key
    om-0003
    source section id
    NCT00084682-om-0003
    source outcome index
    3
    endpoint
    Overall Survival
    endpoint definition
    All time to event endpoints will be evaluated using Kaplan Meier estimates and survival curves will be generated based on these estimates. One and two-year survival and median survival time (if attained) will be estimated and reported with 95% confidence limits. If the sample sizes are sufficient, subgroup analysis based on baseline factors will be performed using the log rank test to compare survival curves.
    time origin
    Up to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    data not collected
    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-laryngeal-cancer-recurrent-46e24458
    nct id
    NCT00084682
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Romidepsin)
    regimen
    Patients receive FR901228 (depsipeptide) IV at 13 mg/m\^2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00084682-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-recurrent-46e24458
    nct id
    NCT00084682
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Romidepsin)
    regimen
    Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00084682-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-recurrent-46e24458
    nct id
    NCT00084682
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Romidepsin)
    regimen
    Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00084682-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-recurrent-46e24458
    nct id
    NCT00084682
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Romidepsin)
    regimen
    Patients receive FR901228 (depsipeptide) IV at 13 mg/m\^2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00084682-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-recurrent-46e24458
    nct id
    NCT00084682
    harm key
    EG000
    source section id
    NCT00084682-ae
    event group key
    EG000
    event group label
    Treatment (Romidepsin)
    serious affected
    12
    serious at risk
    14
    other affected
    11
    other at risk
    14
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer-recurrent-46e24458
    nct id
    NCT00084682
    qol key
    qol-0003
    source section id
    NCT00084682-om-0003
    source outcome index
    3
    instrument
    FACT
    instrument basis
    matched 'factors' in the study's own wording
    scale title
    Overall Survival
    measure definition
    All time to event endpoints will be evaluated using Kaplan Meier estimates and survival curves will be generated based on these estimates. One and two-year survival and median survival time (if attained) will be estimated and reported with 95% confidence limits. If the sample sizes are sufficient, subgroup analysis based on baseline factors will be performed using the log rank test to compare survival curves.
    time frame
    Up to 2 years
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    data not collected
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice