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

Conditions

Paget's Disease of the Vulva

Trial Phase

Phase 2

Trial Purpose and Description

Trial Purpose

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.


Trial Description

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

Participation Guidelines

Age:
18 Years and older
Gender:
Female

Eligibility Criteria


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
Sponsor:
Genentech
Yale University
Dates:
August 2011
Last Updated:
August 31, 2011
Study HIC#:
1004006704

Clinicaltrials.gov ID: NCT01427244