extramammary Paget'
Conditions
Interventions
Chemotherapy Q3W, 3 cycle docetaxel 75mg/sqm trastuzumab 8mg/kg(first cycle), 6mg/kg(second, third cycle)
Sponsors
Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Have histologically confirmed extramammary Paget's disease as follows. unresectable or metastatic disease Her-2 positive 2) Provide written informed consent for the study. 3) Be male or female subjects, age 20 years or older on day of signing consent. 4) LVEF >= 50% 5) Have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. 6) Have the presence of at least one measurable lesion by CT or MRI per RECIST 1.1 criteria. 7) Have laboratory parameters within Protocol-defined range. a) Absolute neutrophil count >= 1,500 /mm3 b) Platelets >= 100,000 /mm3 c) Hemoglobin >= 10 g/dL d) Bilirubin <= 2.0 mg/dL e) AST and ALT <= 100 IU/L g) Serum creatinine <= 1.5mg/dL 8) Prior therapy for extramammary Paget's disease was completed at least 4 weeks before treatment initiation.
Exclusion criteria
Exclusion criteria: 1) Have a history of hypersensitivity to components of the chemotherapeutic drugs 2) Women who may possibly be pregnant or pregnant 3) Patients with severe cardiac dysfunction 4) Has known active central nervous system (CNS) metastasis. 5) Has uncontrolled disease that might confound the results of the study, or is not best interest of the subject to participate, in the opinion of the treating investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, Efficacy(ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| duration of overall response duration of stable disease progression free survival overall survival | — |
Countries
Japan
Contacts
Public ContactIkuko Hirai
Keio University School of Medicine Depertment of Dermatology
Outcome results
None listed