Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy

Yung Shin Pharm

Status: Completed

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

Treatments: Drug: Taxotere; Drug: Nolbaxol; Drug: cisplatin

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02972216

YSP RFH3001-01

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Nolbaxol

Description:

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.

Treatment:

Drug: cisplatin

Drug: Nolbaxol

Taxotere

Description:

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.

Treatment:

Drug: cisplatin

Drug: Taxotere