The combination therapy of docetaxel and trastuzumab

Phase 2

• Conditions: Extramammary Paget's disease; Other disease of skin or skin tissue

• Registration Number: JPRN-jRCTs031180073
• Lead Sponsor: Funakoshi Takeru

Brief Summary

This prospective trial provided first evidence for the treatment of metastatic EMPD. The ORR after 3 cycles was 76.9 % (n = 10/13; 90% CI: 50.5-93.4) including 5 complete responses (38.5%). The lower bound for the 90% CI was greater than the pre-specified threshold of the ORR (35%), and the primary study hypothesis (ORR > 35%) was demonstrated. Docetaxel and trastuzumab combination treatment demonstrated a favorable clinical effect and acceptable tolerability that it can be a good treatment option for HER2

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-09
• Study Completion: 2021-07-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 13

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified