Phase I trial of Docetaxel+Cisplatin+Cetuximab(TPE) for recurrent/metastatic head and neck squamous cell carcinoma
Phase 1
- Conditions
- head and neck squamous cell carcinoma
- Registration Number
- JPRN-UMIN000013170
- Lead Sponsor
- Osaka University Graduate School of Medicine Otorhinolaryngolory-Head and Neck Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method completion rate of treatment
- Secondary Outcome Measures
Name Time Method response rate, adverse events