Clinical Trials List
2014-04-01 - 2016-09-30
Phase III
Terminated7
ICD-10C44.42
Squamous cell carcinoma of skin of scalp and neck
Phase III Study of IV Vinflunine in Combination With Methotrexate Versus Methotrexate Alone in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With Platinum-based Chemotherapy
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Trial Applicant
Orient EuroPharma Co., Ltd.
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Sponsor
Orient Pharma Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/19
Investigators and Locations
Co-Principal Investigator
- Mu-Hsin Chang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 朱崧肇 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Cheng-Lung Hsu Division of Hematology & Oncology
- Tzu-Chen Yen Division of Nuclear Medicine
- Chia-Hsun Hsieh Division of Hematology & Oncology
- Shu-Hang Ag Division of Radiology
- Chi-Ting Liau Division of Hematology & Oncology
- 廖俊達 Division of Otolaryngology
- Tung-Chieh Chang Division of Radiation Therapy
- Li-Yu Lee Division of Others -
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 劉建廷 Division of Hematology & Oncology
- Shau-Hsuan Li Division of Hematology & Oncology
- 陳彥豪 Division of Hematology & Oncology
- Yu-Li Su Division of Hematology & Oncology
- Tai-Jan Chiu Division of Hematology & Oncology
- 吳佳哲 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- HUAI-CHENG HUANG Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Overall Survival in the ITT Population (Months) [ Time Frame: Participants will be followed till death (if they are not lost for follow-up), an expected average of 7.5 months ]
Time from randomization to the date of death or last follow-up. The survival duration of patients still alive, was censored at the date of last contact or last follow-up.
Secondary Outcome Measures :
Progression Free Survival [ Time Frame: an expected average of 4 months ]
Time measured from the date of randomisation until date of progression or death from any cause (whichever came first)
Objective Response Rate (ORR) [ Time Frame: 6 weeks ]
The objective response is defined as the best response designation recorded across all time points from the date of randomisation until disease progression.
Disease Control Rate [ Time Frame: 30 months ]
Percentage of best overall responses CR, PR and SD in the analysed population
Duration of Response [ Time Frame: 30 months ]
Duration of objective response will be measured for responders (CR+PR) from the time for CR or PR until the 1st date of documentation of recurrent or progressive disease or the date of death any cause.
Inclution Criteria
Histologically or cytologically confirmed recurrent and/or metastatic squamous cell carcinoma
Documented progressive disease after chemotherapy for locoregionally advanced or recurrent/metastatic SCCHN which included a platinum derivative
Measurable or non measurable disease
adequate haematological, hepatic and renal functions
WHO performance status < 1
Exclusion Criteria
Nasopharyngeal carcinoma
History of brain or leptomeningeal involvement
Albumin level < 35 g/L
Patients with weight loss ≥ 5% within the last 3 months
Grade > 2 peripheral neuropathy at study entry
"Third space" fluids (pleural effusion, ascites, massive edema)
Prior treatment with vinca-alkaloids and methotrexate
The Estimated Number of Participants
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Taiwan
50 participants
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Global
530 participants
