Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy

Study Overview
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Brief Summary
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A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of Docetaxel-Based Chemotherapy

Official Title
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A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of Docetaxel-Based Chemotherapy

Conditions
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Nonsmall Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck

Intervention / Treatment
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* Drug: Nolbaxol
* Drug: Taxotere
* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Histologically or cytologically confirmed unresectable locally advanced NSCLC with progressed or recurred after no more than four previous docetaxel-free chemotherapy regimens, or unresectable locally advanced or metastatic SCCHN or recurred after previous docetaxel-free chemotherapy regimens Exclusion Criteria: Women who are nursing or pregnant during the study period; Patients with carcinoid tumors, small-cell carcinoma of the lung; A history of another malignancy within the last five years (except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the uterine cervix); Any other morbidity or situation with contraindications for chemotherapy (e.g. active infection, myocardial infarction in the preceding 6 months); Neutrophil counts < 1,500 cells/mm3; A history of hypersensitivity to docetaxel or cisplatin; Symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias; Subjects have active hepatitis; Subjects are known positive for Human Immunodeficiency Virus (HIV); Any condition judged by investigator, participates the study will jeopardize patient's wellbeing

Ages Eligible for Study
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Minimum Age: 20 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nolbaxol<br>For Nonsmall Cell Lung Cancer (NSCLC) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour every 3 weeks (a study medication cycle) and up to 4 study medication cycles throughout this study. For Squamous Cell Carcinoma of the Head and Neck (SCCHN) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour followed by cisplatin 60   75 mg/m2 for 1-3 hours or based on the general practice of the site every 3 weeks and up to 4 study medication cycles throughout this study. | Drug: Nolbaxol<br> <br> * Other names: docetaxel;Drug: cisplatin<br> <br> |
| Taxotere<br>For Nonsmall Cell Lung Cancer (NSCLC) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour every 3 weeks (a study medication cycle) and up to 4 study medication cycles throughout this study. For Squamous Cell Carcinoma of the Head and Neck (SCCHN) Docetaxel (either Group I or Group II) 60 mg/m2 will be administrated by intravenous infusion for 1 hour followed by cisplatin 60   75 mg/m2 for 1-3 hours or based on the general practice of the site every 3 weeks and up to 4 study medication cycles throughout this study. | Drug: Taxotere<br> <br> * Other names: docetaxel;Drug: cisplatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) |  | Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) |  | Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months. | 
| Adverse Events as a measure on safety |  | Adverse event will be evaluated during the study regimens treatment period and up to 8 weeks after the last dose of study regimen visit. |