Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy
Study Details
Study Description
Brief Summary
A Post-marketing Surveillance Study to Evaluate the Effectiveness and Safety of Docetaxel-Based Chemotherapy
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Nolbaxol 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
Other Names:
Drug: cisplatin
|
| Taxotere 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
Other Names:
Drug: cisplatin
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Yung Shin Pharm. Ind. Co., Ltd.
- Taichung Veterans General Hospital
- National Cheng-Kung University Hospital
- Tri-Service General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YSP RFH3001-01