head and neck squamous cell carcinoma
Conditions
Interventions
docetaxel, cisplatin, cetuximab
Sponsors
Osaka University Graduate School of Medicine Otorhinolaryngolory-Head and Neck Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Proven recurrent or metastatic head and neck cancer with histologically diagnosed as squamous cell carcinoma 2) Measurable disease 3) ECOG PS 0 or 1 4) Age is 20 years or older 5) Adequate organ function 6) Life expectancy of at least 3 months 7) Women of child-bearing potential and men who are able to father a child agree with using adequate contraception 8) Written informed consent to the study signed by the patient
Exclusion criteria
Exclusion criteria: 1) Past history of chemotherapy within 3 months 2) Past history of surgery or radiotherapy within 4 weeks 3) Double cancer within 2 years 4) Brain metastasis with active symptoms 5) Severe myelosuppressive or infectious status 6) Pulmonary fibrosis, acute lung injury, interstitial pneumonia 7) Other severe disease such as heart failure, kidney failure 8) Past history of allergy against docetaxel, cisplatin or cetuximab 9) Pregnant or nursing women 10) In the middle of other chemotherapy 11) Past history of cetuximab 12) Other significant disease that in the investigator's opinion would exclude the subject from the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| completion rate of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate, adverse events | — |
Countries
Japan
Contacts
Public ContactHidenori Inohara
Osaka University Graduate School of Medicine Otorhinolaryngolory-Head and Neck Surgery
Outcome results
None listed