Evaluation of Trastuzumab In Patients With HER2 Positive Persistent Or Recurrent Vulvar Paget's Disease
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
Inclusion Criteria:

 -  recurrent or persistent vulvar Paget's disease with overexpression of HER2 by
 immunohistochemistry and or fluorescence in situ hybridization (FISH)

 -  Biopsy for histologic confirmation

 -  Measurable disease

 -  Karnofsky score of 50-100

 -  recovered from effects of recent surgery, radiotherapy, or chemotherapy

 -  free of active infection requiring antibiotics

 -  adequate bone marrow function,renal function,hepatic function,cardiac
 function,WOCBP-neg.serum pregnancy,meet requirements in section 7.0

 Exclusion Criteria:

 -  no measurable disease

 -  tumors not HER2 positive by immunohistochemistry FISH

 -  prior therapy with any anti-HER2 monoclonal antibody preparation

 -  Karnofsky score of 0-40

 -  other invasive malignancies, with the exception of non-melanoma skin cancer

 -  Patients requiring supplemental oxygen

 -  unstable medical conditions in the opinion of the treating physician place them at
 unacceptably increased risk from trastuzumab therapy

 -  Patients with active or unstable cardiac disease, or myocardial infarction within 6
 months