Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy

NCT02972216 | Completed

• 1 other identifier: YSP RFH3001-01
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Every 8 weeks after post-dosing follow-up visit, and conducted until disease progression or up to 11 months.

Secondary Outcomes (2)

• 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.

Study Arms (2)

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; 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; Drug: cisplatin

Interventions

Nolbaxol DRUG

Also known as: docetaxel

Nolbaxol

Taxotere DRUG

Also known as: docetaxel

Taxotere

cisplatin DRUG

Nolbaxol; Taxotere

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck

Interventions

Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 23, 2016
• Study Start: November 1, 2014
• Primary Completion: October 1, 2016
• Last Updated: November 23, 2016

Record last verified: 2016-11