Phase I/II trial of S-1+Nedaplatin+Cetuximab for recurrent/metastatic head and neck squamous cell carcinoma
Phase 1
- Conditions
- head and neck squamous cell carcinoma
- Registration Number
- JPRN-UMIN000012074
- Lead Sponsor
- Kyorin University School of Medicine, Department of Otolaryngology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: Dose limited toxicity Phase II: response rate
- Secondary Outcome Measures
Name Time Method Phase II: Overall survival, disease free survival, disease control rate, safety