Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yung Shin Pharm. Ind. Co., Ltd.
• Collaborators: National Cheng-Kung University Hospital; Taichung Veterans General Hospital; Tri-Service General Hospital
• Treatments: Cisplatin; Docetaxel

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:

1. Women who are nursing or pregnant during the study period;

2. Patients with carcinoid tumors, small-cell carcinoma of the lung;

3. 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);

4. Any other morbidity or situation with contraindications for chemotherapy (e.g. active infection, myocardial infarction in the preceding 6 months);

5. Neutrophil counts < 1,500 cells/mm3;

6. A history of hypersensitivity to docetaxel or cisplatin;

7. Symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias;

8. Subjects have active hepatitis;

9. Subjects are known positive for Human Immunodeficiency Virus (HIV);

10. Any condition judged by investigator, participates the study will jeopardize patient's wellbeing