TriangleNCT00749892 · STUDY IN CONTEXT
Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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
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.
Estimated 4-Year Disease-Free Survival
Reported safety
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-ureter-neoplasm
- nct id
- NCT00749892
- trial label
- Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-ureter-neoplasm
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-ureter-neoplasm
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-ureter-neoplasm
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-ureter-neoplasm
- 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