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NCT00749892 · STUDY IN CONTEXT

Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial Cancer

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

The response rate is the number of patients with urothelial cancer treated with erlotinib prior to cystectomy. The response is defined as the absence of residual cancer in the surgical removed tissue (i.e., pT0). A responder is defined as a participant with the pathological stage of pT0 meaning that there is no evidence of disease.

two participants did not take any eroltinib and three participants stopped erlotinib early due to intolerable side effects.

→

secondary · NOT_POSTED

Estimated 4-Year Disease-Free Survival

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-bladder-cancer-recurrent-a15d6191
nct id
NCT00749892
trial label
Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial Cancer
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
2
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-bladder-cancer-recurrent-a15d6191
    nct id
    NCT00749892
    outcome key
    om-0000
    source section id
    NCT00749892-om-0000
    source outcome index
    0
    endpoint
    Response Rate
    endpoint definition
    The response rate is the number of patients with urothelial cancer treated with erlotinib prior to cystectomy. The response is defined as the absence of residual cancer in the surgical removed tissue (i.e., pT0). A responder is defined as a participant with the pathological stage of pT0 meaning that there is no evidence of disease.
    time origin
    Determined at the time of surgery or cystectomy
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    two participants did not take any eroltinib and three participants stopped erlotinib early due to intolerable side effects.
    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-bladder-cancer-recurrent-a15d6191
    nct id
    NCT00749892
    outcome key
    om-0001
    source section id
    NCT00749892-om-0001
    source outcome index
    1
    endpoint
    Estimated 4-Year Disease-Free Survival
    endpoint definition
    Estimated 4-Year Disease-Free Survival
    time origin
    4 years
    analysis role
    secondary
    reporting status
    NOT_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-bladder-cancer-recurrent-a15d6191
    nct id
    NCT00749892
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Pre-surgical Erlotinib Treatment
    regimen
    Erlotinib 150 mg by mouth daily for 3 weeks followed by cystectomy within 24 hours of the last dose.
    analyzed count
    26
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00749892-om-0000#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-bladder-cancer-recurrent-a15d6191
    nct id
    NCT00749892
    harm key
    EG000
    source section id
    NCT00749892-ae
    event group key
    EG000
    event group label
    Pre-surgical Erlotinib Treatment
    serious affected
    5
    serious at risk
    31
    other affected
    19
    other at risk
    31
    frequency threshold
    5
    collection period
    Evaluated for 2 months once drug therapy started.
    event definition
    Toxicities were measured at weekly visit while on therapy using the NCI CTCAE v3.0.
    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