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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01427244
Recruitment Status : Withdrawn
First Posted : September 1, 2011
Last Update Posted : June 16, 2014
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE August 31, 2011
First Posted Date  ICMJE September 1, 2011
Last Update Posted Date June 16, 2014
Study Start Date  ICMJE August 2011
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2011)
measurement of the longest diameter for all target lesions [ Time Frame: 5 years ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2011)
To assess the safety profile of trastuzumab in persistent or recurrent vulvar Paget's disease [ Time Frame: 5 years ]
To assess the safety profile for all patients who receive any amount of trastuzumab will be evaluable for toxicity.At each visit, a brief focused history will be obtained and any indication of treatment related toxicity will be evaluated by appropriate examination and/or laboratory/radiographic studies using the CTCAE v4.0 toxicity grades for both laboratory and non-laboratory data.The evaluation period should extend from date of first treatment until 30 days (or longer if so specified) from the last dose, or until resolution from all acute toxicities associated with the drug administration.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Trastuzumab In Patients With HER2 Positive Persistent Or Recurrent Vulvar Paget's Disease
Official Title  ICMJE A Phase II Evaluation of Trastuzumab In Patients With HER2 Positive Persistent Or Recurrent Vulvar Paget's Disease
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Paget's Disease of the Vulva
Intervention  ICMJE Drug: trastuzumab
monoclonal antibody
Study Arms  ICMJE Experimental: Trastuzumab
Open Label
Intervention: Drug: trastuzumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 12, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2011)
29
Estimated Study Completion Date  ICMJE September 2015
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01427244
Other Study ID Numbers  ICMJE 1004006704
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Principal Investigator: Thomas J. Rutherford, MD, PhD Yale University
PRS Account Yale University
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP