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NCT00476476 · ClinicalTrials.gov registry record · Phase 2

Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar

A Phase 2 study, sponsored by Dana-Farber Cancer Institute.

Completed
Registry status
Phase 2
Development phase
41
Enrollment target

NCT00476476 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 41 participants.

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The verdict

NCT00476476, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.

COMPLETED
Registry status
Phase 2
Development phase
41 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Erlotinib

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2006-12
Est. Completion 2012-10
Phase Phase 2

Sponsor

Dana-Farber Cancer Institute

781 total trials

What the Registry Record Tells You About NCT00476476

The ClinicalTrials.gov registry entry for NCT00476476 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Erlotinib is the first listed.

NCT00476476 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00476476 about?

NCT00476476 is a clinical study titled "Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar". 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 ...

What is the current status of trial NCT00476476?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2006-12. Estimated completion is 2012-10.

What interventions are being tested in trial NCT00476476?

The interventions under investigation include: Erlotinib (DRUG).

Who is sponsoring clinical trial NCT00476476?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.