Paget's Disease of the Vulva Clinical Trial
Official title:
A Phase II Evaluation of Trastuzumab In Patients With HER2 Positive Persistent Or Recurrent Vulvar Paget's Disease
This is a phase II open-label study of the activity and safety of trastuzumab in patients with vulvar Paget's disease with overexpression of HER2 on biopsy.
The primary objective will be to estimate the anti-tumor activity of trastuzumab by
evaluating the response to trastuzumab therapy in patients with recurrent or persistent
vulvar Paget's disease demonstrating HER2/neu overexpression by immunohistochemistry and/ or
FISH ((fluorescence in situ hybridization).
The secondary objectives:
- To evaluate the quality of life, based on the severity of the patients' vulvar itching
on a 4-point verbal rating scale from 0 to 3 (0=no itching, 1=mild itching/ bothersome,
2=moderate itching/ troublesome, 3=severe itching/ extremely troublesome) as well as on
the severity of the patients' vulvar pain on a numeric pain scale from 0-10 (0=no pain,
1-3=mild pain, 4-6=moderate pain, 7-10=severe pain).
- To assess the frequency and severity of observed adverse effects
- To assess the frequency/ incidence of HER2 in Paget's disease of the vulva
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment