Study to Evaluate the Efficacy and Safety of Docetaxel Polymeric Micelle (PM) in Recurrent or Metastatic HNSCC

Study Overview
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Brief Summary
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A phase II study to evaluate the efficacy and safety of Docetaxel-PM in recurrent or metastatic head and neck squamous cell carcinoma

Official Title
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A Phase II Study to Evaluate the Efficacy and Safety of Docetaxel-PM in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Docetaxel-PM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were histologically or cytologically diagnosed as having oral cavity, oropharynx, hypopharynx, or larynx squamous cell carcinoma with recurrent and metastatic evidence and who cannot be treated by salvage surgery or radiotherapy Time of disease progression, regardless of whether that treatment or after platinum-based therapy ①Patients who have disease progression after concurrent chemoradiotherapy of curative purpose (including induction chemotherapy) including a platinum-based (cisplatin or carboplatin) chemotherapy ② Patients who have disease progression after primary or secondary treatment of palliative purpose including a platinum-based (cisplatin or carboplatin) chemotherapy Patients who aged 20 years or older and under 79 years old Patients whose Eastern Cooperative Oncology Group (ECOG) performance scores are 0-2 Patients who have one measurable lesion at least by RECIST criteria 1.1 Patients who show adequate function of organ: bone marrow: Absolute Neutrophil count (ANC) ≥ 1,500/μL, Platelet count ≥ 100,000/μ, Hb≥ 9.0 g/dl (allowed blood transfusion) Liver: ① with no evidence of liver metastasis; Total bilirubin ≤ 1.5mg/dl, alkaline phosphatase (ALP), aspartate transaminase (AST), alanine transaminase (ALT) ≤ 2.0 X upper limit of normal (ULN) ② with liver metastasis; bilirubin ≤ 3.0 X ULN, aspartate transaminase (AST), alanine transaminase (ALT) ≤ 5.0 X ULN Kidney: creatinine ≤ 1.5 X ULN Patients who have signed written consent forms prior to participation in the clinical trial Exclusion Criteria: Patients who have Primary tumor of nasopharynx Patients who have received treatment prior regimen of three or more drugs Patients who have Primary malignant tumors of other sites (except if; early cervical cancer, skin basal cell cancer received appropriate treatment, Malignant tumor without recurrent state treated five years previously) Previous radiotherapy is allowed, patients who should be completed radiotherapy before 4 weeks prior to the initial administration of the investigational product Patients who have received a major surgery within 4 weeks prior to the initial administration of the investigational product or patients who does not recover after major surgery Patients who have severe diseases or medical condition as follows Congestive heart failure(NYHA class III or IV) Unstable angina, cardiac infarction within 6 months Second-degree atrioventricular (AV) block or more, clinically cardiac arrhythmia that needs drug therapy Uncontrollable Hypertension Hepatic cirrhosis (≥ Child class B) Interstitial lung disease Mental disorder not to comply with the protocol Uncontrolled diabetes Uncontrolled ascites or pulmonary edema Active infection Pregnant or lactating women Patients considered inappropriate to participating the study by the investigator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel-PM<br>Docetaxel-PM 75mg/m2 IV infusion | Drug: Docetaxel-PM<br>* Docetaxel PM 75mg/m2 IV infusion<br>* Other names: Nanoxel M;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate as assessed by RECIST v1.1 | Response is confirmed at least 4 weeks later. Assessment: every 6 weeks (treatment period), every 2 months (follow-up period) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | Assessment: every 2 months (follow-up period) | 2 years | 
| Disease control rate (DCR) | DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease | 2 years | 
| Overall survival | Assessment: every 2 months (follow-up period) | 2 years | 
| Number of participants with adverse events as assessed by CTCAE v4.0 |  | 2 years | 
| Incidence rate of hypersensitivity reaction to Docetaxel-PM |  | 2 years |