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Completed Phase 2 Interventional Results available

Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar

ClinicalTrials.gov ID: NCT00476476

Public ClinicalTrials.gov record NCT00476476. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 19, 2026, 7:04 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase II Trial of Tarceva (Erlotinib) in Women With Squamous Cell Carcinoma of the Vulvar

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

In this research study we are looking to see how vulvar cancer responds to erlotinib therapy. Two distinct patient populations are targeted: women with locally advanced measurable squamous cell carcinoma of the vulva, primary or recurrent, who are candidates for definitive treatment with surgery or chemoradiation (Cohort 1) and women with radiographically measurable distant metastatic cancer either at time of presentation or with recurrence (Cohort 2). Another goal of this study is to learn more about the proteins and genes present in vulvar cancer and how they may affect response to erlotinib. Erlotinib treats cancer by preventing cancer cells from growing and multiplying. It does this by blocking certain proteins that are on the surface of some types of cancer cells. Laboratory tests show that vulvar cancer cells have high levels of these proteins.

Study identification

NCT ID
NCT00476476
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
41 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2006
Primary completion
Sep 30, 2012
Completion
Sep 30, 2012
Last update posted
May 6, 2015

2006 – 2012

United States locations

U.S. sites
4
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Beth Israel Deaconess Medical Center Boston Massachusetts 02115
Massachusetts General Hospital Boston Massachusetts 02214
Dana-Farber Cancer Institute Boston Massachusetts 02215
Women and Infants Hospital of Rhode Island Providence Rhode Island 02905

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00476476, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 6, 2015 · Synced Sep 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00476476 live on ClinicalTrials.gov.

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