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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: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT00476476 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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 p
Interventions
- DRUG Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2006-12 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
What the finished NCT00476476 record still lists
NCT00476476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 1 intervention - of which Erlotinib is the first listed.
NCT00476476 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00476476's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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