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

NCT ID: NCT01427244

Last Updated: 2014-06-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2015-09-30

Brief Summary

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.

Detailed 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

Conditions

Paget's Disease of the Vulva

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trastuzumab

Open Label

Group Type: EXPERIMENTAL

trastuzumab

Intervention Type: DRUG

monoclonal antibody

Interventions

trastuzumab

monoclonal antibody

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas J. Rutherford, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1004006704

Identifier Type: -

Identifier Source: org_study_id