Trial · NCT00749892
Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial Cancer
NCT00749892, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2020-09-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial Cancer. Trials, record NCT00749892. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00749892
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial Cancer
- NCT number
- NCT00749892
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
Recurrent Bladder Urothelial Carcinoma, Recurrent Renal Pelvis Urothelial Carcinoma, Recurrent Ureter Urothelial Carcinoma, Recurrent Urethral Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage 0a Renal Pelvis Cancer AJCC v8, Stage 0a Ureter Cancer AJCC v8, Stage 0a Urethral Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage 0is Renal Pelvis Cancer AJCC v8, Stage 0is Ureter Cancer AJCC v8, Stage 0is Urethral Cancer AJCC v8, Stage II Bladder Cancer AJCC v8, Stage II Renal Pelvis Cancer AJCC v8, Stage II Ureter Cancer AJCC v8, Stage II Urethral Cancer AJCC v8, Stage III Renal Pelvis Cancer AJCC v8, Stage III Ureter Cancer AJCC v8, Stage III Urethral Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8
- Interventions
- Erlotinib Hydrochloride
- First posted
- 2008-09-09
- Last updated
- 2020-09-10
- Results first posted
- 2020-09-10
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate | Determined at the time of surgery or cystectomy | 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. |
| Secondary | Estimated 4-Year Disease-Free Survival | 4 years |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate | Determined at the time of surgery or cystectomy | two participants did not take any eroltinib and three participants stopped erlotinib early due to intolerable side effects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Estimated 4-Year Disease-Free Survival | 4 years |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate | Pre-surgical Erlotinib Treatment | Number of Responders | 8 | Participants | |
| Response Rate | Pre-surgical Erlotinib Treatment | Number of Non Responders | 18 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pre-surgical Erlotinib Treatment | 34 | |
| Overall Study | COMPLETED | Pre-surgical Erlotinib Treatment | 31 | |
| Overall Study | NOT COMPLETED | Pre-surgical Erlotinib Treatment | 3 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rash | Skin and subcutaneous tissue disorders | Pre-surgical Erlotinib Treatment | 15 | 31 | |
| other | Diarrhea | Gastrointestinal disorders | Pre-surgical Erlotinib Treatment | 6 | 31 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Pre-surgical Erlotinib Treatment | 5 | 31 | |
| other | Decreased Neutrophils/Grabulocytes | Blood and lymphatic system disorders | Pre-surgical Erlotinib Treatment | 2 | 31 | |
| serious | Rash | Skin and subcutaneous tissue disorders | Pre-surgical Erlotinib Treatment | 2 | 31 | |
| serious | Decreased Neutrophils/Grabulocytes | Blood and lymphatic system disorders | Pre-surgical Erlotinib Treatment | 1 | 31 | |
| serious | Adrenal insufficiency | Endocrine disorders | Pre-surgical Erlotinib Treatment | 1 | 31 | |
| serious | Fatigue | General disorders | Pre-surgical Erlotinib Treatment | 1 | 31 | |
| serious | Infection-wound | Infections and infestations | Pre-surgical Erlotinib Treatment | 1 | 31 | |
| serious | Decreased Leukocytes (Total WBD) | Blood and lymphatic system disorders | Pre-surgical Erlotinib Treatment | 1 | 31 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pre-surgical Erlotinib Treatment | 0 | 31 |
| Total, other adverse events | Pre-surgical Erlotinib Treatment | 19 | 31 |
| Total, serious adverse events | Pre-surgical Erlotinib Treatment | 5 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00749892
GET https://conductscience.org/api/trials/v1/NCT00749892/registered