Trial · NCT02169284
Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery
NCT02169284, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2020-07-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery. Trials, record NCT02169284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02169284
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery
- NCT number
- NCT02169284
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Bladder Carcinoma, Recurrent Bladder Carcinoma
- Interventions
- Erlotinib Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study, Placebo, Quality-of-Life Assessment, Therapeutic Conventional Surgery
- First posted
- 2014-06-23
- Last updated
- 2020-07-07
- Results first posted
- 2020-07-07
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor | Up to 18 hours after last study drug dose (on day 28) | EGFR phosphorylation will be assessed using Immunohistochemistry (IHC), greater mean optical density is associated with greater phosphorylation. The difference between the placebo group and the erlotinib hydrochloride group will be tested as-randomized using a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test. |
| Secondary | EGFR Phosphorylation in Neoplastic Bladder Epithelium 9-18 Hours Post-study Dose | Up to 18 hours after last study drug dose (on day 28) | EGFR phosphorylation will be assessed using Immunohistochemistry (IHC), greater mean optical density is associated with greater phosphorylation. |
| Secondary | Pharmacokinetic Parameters: Erlotinib in Blood | Baseline, day 8, and day 16 (day of surgery) | Will be summarized by treatment arm (and, if applicable, by visit) with appropriate descriptive statistics. |
| Secondary | Pharmacokinetic Parameters: OSI-420 in Blood | Baseline, day 8, and day 16 (day of surgery) | Will be summarized by treatment arm (and, if applicable, by visit) with appropriate descriptive statistics. |
| Secondary | Frequency of Urination Symptoms in Men Only, Graded According to International Prostate Symptom Score (I-PSS) | Baseline up to 18 hours after last study drug dose (on day 28) | A well documented survey called the International Prostate Symptom Score (I-PSS) of urination symptoms which correlates with prostatic hyperplasia in men will be filled out by men at baseline and end of study. The I-PSS is an 8-item survey; 7 questions scored from 0-5 where 0 is 'none' or 'not at all' and 5 is 'five times' or 'almost always'. The sum of the scores for the first 7 questions has a total range of 0-35 where 0 is asymptomatic, 1-7 is mild symptoms, 8-19 is moderate symptoms, and 20-35 are severe symptoms. A final quality of life question is scored from 0-6 where 0 (delighted) to 6 (terrible). This question serves as a conversation starting point between the patient and physician. |
| Secondary | Expression of E-cadherin | At time of surgery (approximately day 16) | E-Cadherin expression will be assessed using Immunohistochemistry (IHC), greater membrane optical density was associated with greater expression. A two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used. |
| Secondary | Percentage of Cells Expressing Ki67 | At time of surgery (approximately day 16) | Ki-67 expression will be assessed using Immunohistochemistry (IHC), greater positivity was associated with greater expression. A two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used. |
| Secondary | Difference Between Normal and Neoplastic Tissue Phosphorylated ERK | At time of surgery (approximately day 16) | Phosphorylated ERK will be assessed using Immunohistochemistry (IHC), greater mean optical density is associated with greater expression. A two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used. |
| Secondary | Difference Between Normal and Neoplastic Tissue of p53 | At time of surgery (approximately day 16) | p53 expression will be assessed using Immunohistochemistry (IHC), greater nucleus optical density and positivity was associated with greater expression. A two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used. |
| Secondary | Difference Between Normal and Neoplastic Tissue of Let-7 | At time of surgery (approximately day 16) | A two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor | Up to 18 hours after last study drug dose (on day 28) | Number analyzed differs from number of participants in each arm for two reasons: sample size insufficient for analysis and sample not obtained. | optical density | MEAN |
| SECONDARY | EGFR Phosphorylation in Neoplastic Bladder Epithelium 9-18 Hours Post-study Dose | Up to 18 hours after last study drug dose (on day 28) | Number analyzed differs from number of participants in each arm for two reasons: sample size insufficient for analysis and sample not obtained. | Optical Density (OD) | MEAN |
| SECONDARY | Pharmacokinetic Parameters: Erlotinib in Blood | Baseline, day 8, and day 16 (day of surgery) | Number analyzed differs from number of participants in each arm for two reasons: sample size insufficient for analysis and sample not obtained. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Parameters: OSI-420 in Blood | Baseline, day 8, and day 16 (day of surgery) | Number analyzed differs from number of participants in each arm for two reasons: sample size insufficient for analysis and sample not obtained. | ng/mL | MEAN |
| SECONDARY | Frequency of Urination Symptoms in Men Only, Graded According to International Prostate Symptom Score (I-PSS) | Baseline up to 18 hours after last study drug dose (on day 28) | A participant in the placebo group had no survey response at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Expression of E-cadherin | At time of surgery (approximately day 16) | Number analyzed differs from number of participants in each arm for two reasons: sample size insufficient for analysis and sample not obtained. | Optical Density (OD) | MEAN |
| SECONDARY | Percentage of Cells Expressing Ki67 | At time of surgery (approximately day 16) | Number analyzed differs from number of participants in each arm for two reasons: sample size insufficient for analysis and sample not obtained. | percentage | MEAN |
| SECONDARY | Difference Between Normal and Neoplastic Tissue Phosphorylated ERK | At time of surgery (approximately day 16) | Number analyzed differs from number of participants in each arm for two reasons: sample size insufficient for analysis and sample not obtained. | Optical Density (OD) | MEAN |
| SECONDARY | Difference Between Normal and Neoplastic Tissue of p53 | At time of surgery (approximately day 16) | Number analyzed differs from number of participants in each arm for two reasons: sample size insufficient for analysis and sample not obtained. As well as there was not enough tissue to complete this analysis for all participants. | Optical Density (OD) | MEAN |
| SECONDARY | Difference Between Normal and Neoplastic Tissue of Let-7 | At time of surgery (approximately day 16) | This analysis was not completed after discussions with DCP. Participant samples were rationed for multiple analyses, Let-7 analysis was determined to be low on the priority list and it was decided to forego this analysis. |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor | Group I (Erlotinib Hydrochloride) | Nucleus P-EGFR in Benign Tissue | 0.216 | Standard Deviation 0.063 | optical density |
| EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor | Group II (Placebo) | Nucleus P-EGFR in Benign Tissue | 0.181 | Standard Deviation 0.073 | optical density |
| EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor | Group I (Erlotinib Hydrochloride) | Cytoplasm P-EGFR in Benign Tissue | 0.159 | Standard Deviation 0.046 | optical density |
| EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor | Group II (Placebo) | Cytoplasm P-EGFR in Benign Tissue | 0.133 | Standard Deviation 0.062 | optical density |
| EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor | Group I (Erlotinib Hydrochloride) | Membrane P-EGFR in Benign Tissue | 0.179 | Standard Deviation 0.053 | optical density |
| EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor | Group II (Placebo) | Membrane P-EGFR in Benign Tissue | 0.148 | Standard Deviation 0.074 | optical density |
| EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor | Group I (Erlotinib Hydrochloride) | Entire Cell P-EGFR in Benign Tissue | 0.190 | Standard Deviation 0.054 | optical density |
| EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor | Group II (Placebo) | Entire Cell P-EGFR in Benign Tissue | 0.159 | Standard Deviation 0.069 | optical density |
| EGFR Phosphorylation in Neoplastic Bladder Epithelium 9-18 Hours Post-study Dose | Group I (Erlotinib Hydrochloride) | Nucleus P-EGFR Tumor Tissue | 0.175 | Standard Deviation 0.060 | Optical Density (OD) |
| EGFR Phosphorylation in Neoplastic Bladder Epithelium 9-18 Hours Post-study Dose | Group II (Placebo) | Nucleus P-EGFR Tumor Tissue | 0.155 | Standard Deviation 0.059 | Optical Density (OD) |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group I (Erlotinib Hydrochloride) | 24 | |
| Overall Study | STARTED | Group II (Placebo) | 13 | |
| Overall Study | COMPLETED | Group I (Erlotinib Hydrochloride) | 24 | |
| Overall Study | COMPLETED | Group II (Placebo) | 12 | |
| Overall Study | NOT COMPLETED | Group I (Erlotinib Hydrochloride) | 0 | |
| Overall Study | NOT COMPLETED | Group II (Placebo) | 1 |
Source ClinicalTrials.gov
Adverse events134
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 | Blood and Lymphatic System Disorders, Other | Blood and lymphatic system disorders | Group I (Erlotinib Hydrochloride) | 1 | 24 | 1 |
| other | Blood and Lymphatic System Disorders, Other | Blood and lymphatic system disorders | Group II (Placebo) | 0 | 13 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Group I (Erlotinib Hydrochloride) | 1 | 24 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Group II (Placebo) | 0 | 13 | 0 |
| other | Lymph Node Pain | Blood and lymphatic system disorders | Group I (Erlotinib Hydrochloride) | 1 | 24 | 1 |
| other | Lymph Node Pain | Blood and lymphatic system disorders | Group II (Placebo) | 0 | 13 | 0 |
| other | Tinnitus | Ear and labyrinth disorders | Group I (Erlotinib Hydrochloride) | 1 | 24 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | Group II (Placebo) | 0 | 13 | 0 |
| other | Endocrine Orders, Other | Endocrine disorders | Group I (Erlotinib Hydrochloride) | 1 | 24 | 1 |
| other | Endocrine Orders, Other | Endocrine disorders | Group II (Placebo) | 0 | 13 | 0 |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group I (Erlotinib Hydrochloride) | 0 | 24 |
| Total, all-cause mortality | Group II (Placebo) | 0 | 13 |
| Total, other adverse events | Group I (Erlotinib Hydrochloride) | 22 | 24 |
| Total, other adverse events | Group II (Placebo) | 8 | 13 |
| Total, serious adverse events | Group I (Erlotinib Hydrochloride) | 1 | 24 |
| Total, serious adverse events | Group II (Placebo) | 2 | 13 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39187984 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| P30CA014520 | UW Comprehensive Cancer Center Support | CAPITINI, CHRISTIAN | UNIVERSITY OF WISCONSIN-MADISON | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group I (Erlotinib Hydrochloride) vs Group II (Placebo): deaths from any cause | Trial comparisons |
| Group I (Erlotinib Hydrochloride) vs Group II (Placebo): serious adverse events | Trial comparisons |
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.
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