The combination therapy of docetaxel and trastuzumab

JRCT ID: jRCTs031180073

Registered date:09/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Extramammary Paget's disease
• Date of first enrollment: 15/04/2017
• Target sample size: 13
• Study type: Interventional

Intervention(s)

Chemotherapy Q3W, 3 cycle
docetaxel 75mg/m2
trastuzumab 8mg/kg(first cycle), 6mg/kg(second, third cycle)

Outcome(s)

• Primary Outcome: Response rate after administration of three dosing cycle
• Secondary Outcome: Duration of response, stable period, progression-free survival, overall survival, adverse event type/ frequency/ severity (CTCAE).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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
f) Serum creatinine <= 1.5mg/dL
8) Prior therapy for extramammary Paget's disease was completed at least 4 weeks before treatment initiation.

Exclude 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.

Related Information

• Primary Sponsor: Funakoshi Takeru
• Source(s) of Monetary Support: CHUGAI PHARMACEUTICAL CO., LTD.,Elmed Eisai Co., Ltd.,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000021311