Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy

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

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

Study Overview

• Status: Completed
• Conditions: Squamous Cell Carcinoma of the Head and Neck; Nonsmall Cell Lung Cancer
• Intervention / Treatment: Drug: cisplatin; Drug: Taxotere; Drug: Nolbaxol

• Study Type: Observational
• Enrollment (Actual): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total of 40 evaluable patients with locally advanced or metastatic NSCLC, SCCHN or esophageal cancer will be equally randomized to either Nolbaxol or Taxotere.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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: cisplatin; Drug: Nolbaxol; Other Names: docetaxel
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: cisplatin; Drug: Taxotere; Other Names: docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 21, 2016
• First Posted (Estimate): November 23, 2016

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: November 21, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Head and Neck Neoplasms; Lung Neoplasms; Carcinoma, Squamous Cell; Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Cisplatin
• Other Study ID Numbers: YSP RFH3001-01