Trial · NCT00476476
Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar
NCT00476476, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2015-03-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar. Trials, record NCT00476476. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00476476
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar
- NCT number
- NCT00476476
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Squamous Cell Carcinoma
- Interventions
- Erlotinib
- First posted
- 2007-05-22
- Last updated
- 2015-05-07
- Results first posted
- 2015-03-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate | Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts). | Response is defined as achieving complete or partial response.Complete response (CR) for both cohorts was defined as resolution of all identified tumor masses on the vulva or disappearance of all target and non-target lesions with no evidence of new lesions documented by two disease assessments at least 4 weeks apart. For cohort 1 pts, a partial response (PR) was defined as a 30% reduction in the product of all diameters of the vulva tumor/tumors compared to baseline measurements. For cohort 2 pts, PR defined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was at least a 30% decrease in the sum of the longest diameter (LD) of all target measurable lesions (baseline sum LD reference). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate | Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts). | The analysis dataset is comprised of response evaluable patients. | proportion of participants | NUMBER |
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 | Erlotinib-Cohort 1 | .35 | 90% Confidence Interval .167 to .580 | proportion of participants | |
| Response Rate | Erlotinib-Cohort 2 | .22 | 90% Confidence Interval .09 to .404 | proportion of participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Erlotinib-Cohort 1 | 17 | |
| Overall Study | STARTED | Erlotinib-Cohort 2 | 24 | |
| Overall Study | Response Evaluable | Erlotinib-Cohort 1 | 17 | |
| Overall Study | Response Evaluable | Erlotinib-Cohort 2 | 23 | |
| Overall Study | COMPLETED | Erlotinib-Cohort 1 | 15 | |
| Overall Study | COMPLETED | Erlotinib-Cohort 2 | 0 | |
| Overall Study | NOT COMPLETED | Erlotinib-Cohort 1 | 2 | |
| Overall Study | NOT COMPLETED | Erlotinib-Cohort 2 | 24 |
Source ClinicalTrials.gov
Adverse events116
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 | Erythema multiforme | Skin and subcutaneous tissue disorders | Erlotinib | 1 | 41 | |
| other | Skin breakdown/decubitus ulcer | Skin and subcutaneous tissue disorders | Erlotinib | 1 | 41 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Erlotinib | 8 | 41 | |
| other | Hematologic-other | Blood and lymphatic system disorders | Erlotinib | 1 | 41 | |
| other | Sinus tachycardia | Cardiac disorders | Erlotinib | 1 | 41 | |
| other | Endocrine-other | Endocrine disorders | Erlotinib | 1 | 41 | |
| other | Dry eye syndrome | Eye disorders | Erlotinib | 1 | 41 | |
| other | Eyelid dysfunction | Eye disorders | Erlotinib | 1 | 41 | |
| other | Tearing | Eye disorders | Erlotinib | 1 | 41 | |
| other | Ocular-other | Eye disorders | Erlotinib | 2 | 41 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Erlotinib | ||
| Total, other adverse events | Erlotinib | 40 | 41 |
| Total, serious adverse events | Erlotinib | 19 | 41 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22750258 | RESULT |
Source PubMed
Grants0
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.
None in this release.
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/NCT00476476
GET https://conductscience.org/api/trials/v1/NCT00476476/events?page=2