Evaluation of Trastuzumab In Patients With HER2 Positive Persistent Or Recurrent Vulvar Paget's D… (NCT01427244) | Clinical Trial Compass
WithdrawnPhase 2
Evaluation of Trastuzumab In Patients With HER2 Positive Persistent Or Recurrent Vulvar Paget's Disease
United States0Started 2011-08
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
measurement of the longest diameter for all target lesions