A Phase II Evaluation of Trastuzumab In Patients With HER2 Positive Persistent Or Recurrent Vulvar Paget's Disease
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
measurement of the longest diameter for all target lesions
Where possible measurement of the target lesion size in 2 perpendicular diameters will be required for follow up. A Change in the product of these 2 diameters affords some estimate of change in tumor size and hence therapeutic efficacy. Response criteria will be based on the RECIST modified response evaluation criteria (appendix I).The reporting of these changes will be on an individual case basis and will be in terms of the best response achieved by that case.
Thomas J. Rutherford, MD, PhD
United States: Institutional Review Board
|Smilow Cancer Hospital at Yale New Haven||New Haven, Connecticut 06510|