head and neck squamous cell carcinoma
Conditions
Interventions
S-1, Nedaplatin, Cetuximab
Sponsors
Kyorin University School of Medicine, Department of Otolaryngology
Saitama Medical University International Medical Center Tokyo Medial University Hchioji Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically diagnosed primary squamous cell carcinoma 2) Proven recurrent or metastatic head and neck cancer (except for epipharynx) 3) Measurable disease 4) Primary radiotherapy and chemotherapy are permitted if the treatment has been completed at least 4 weeks before patient selection. 5) Age of 20-75 years 6) ECOG PS 0 or 1 7) Life expectancy of at least 3 months 8) Adequate organ function 9) Written informed consent to the study signed by the patient 10) the patient who can take meidicine by mouth Not amenable for local treatment for recurrent/ metastatic disease No prior chemotherapy including nedaplatin for the current malignancy Adequate organ function Life expectancy of greater than 3 months Women of child-bearing potential and men who are able to father a child agree with using adequate contraception Written informed consent to the study signed by the patient
Exclusion criteria
Exclusion criteria: 1) Past history of allergy against S-1, Nedaplati or cetuximab 2) pregnancy or the man who wants partner's pregnancy 3) active double cancer 4) active infection disesase 5) Current administration of Flucytosine, fenitoin or warfarin 6) Positivity for hepatitis B or Hepatitis C antigen 7) severe skin disesase 8) interstitial pneumonia 9) severe diarrhea 10) severe renal disease 11) Other significant disease that in the investigator's opinion would exclude the subject from the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Dose limited toxicity Phase II: response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: Overall survival, disease free survival, disease control rate, safety | — |
Countries
Japan
Contacts
Public ContactYasunao Kogashiwa
Kyorin University Department of Otolaryngology
Outcome results
None listed