Cetuximab in combination with S-1 in Treating Patients With Metastatic or Unresectable Head and Neck Cancer
- Conditions
- Head and Neck cancer
- Registration Number
- JPRN-UMIN000010310
- Lead Sponsor
- Juntendo university faculty of medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1)Known hypersensitivity to S-1, fluorouracil, cisplatin, cetuximab or to any of the excipients of these drugs 2)Being treated with other pyrimidine fluoride antineoplastic agents, flucytosine or therapeutic anticoagulation (prophylactic use of warfarin 1 mg per day is allowed) 3)Known Human Immunodeficiency Virus (HIV) infection, active or chronic carrier of hepatitis B virus (HBV) (HBV antigen positive or HBV deoxyribonucleic acid (DNA) positive) or hepatitis C virus (HCV) (HCV antibody positive) 4)Current severe infection, or suspicious of severe infection 5)Significant comorbid disease such as paresis of intestine and ileus. 6)Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest CT 7)Uncontrolled diabetes mellitus 8)Severe heart disease or liver disease 9)Pregnant women are excluded from this study because cetuximab has the potential for teratogenic or abortifacient effects. Women of child-bearing potential and men are also exluded. 10)Inappropriate patients for this study judged by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the objective response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- Secondary Outcome Measures
Name Time Method Overall Survival Progression-Free Survival Safety Patients' Quality of life