Status:
COMPLETED
Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Clinical Research Center for Solid Tumor, Korea
Conditions:
Head and Neck Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of the study is to investigate the efficacy and safety of cetuximab, docetaxel, cisplatin combination as induction therapy in locally advanced head and neck squamous cell carcinoma.
Eligibility Criteria
Inclusion
- Unresectable, locally advanced (cT4b \&/or cN2-3) HNSCC
- ECOG performance status 0-1
- Age 18 or older than 18 years
- Measurable disease by RECIST criteria
- Having signed informed consent
- ALT and AST\<2.5 times ULN
- Serum albumin level ≥3.0g/dL
- Serum AKP \< 2.5 times ULN
- Bilirubin level \< 1.5mg/dL
- Serum creatinine \<1.5 times ULN
- WBC\>3000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>75,000/mm3, Hb\>9g/dl
Exclusion
- Previous cytotoxic chemotherapy for HNSCC
- Radiotherapy for targeted lesions within six months
- Previous EGFR pathway-targeting therapy
- Prior surgery for cancer (excluding diagnostic biopsy within 4 weeks prior to study entry)
- Distant metastatic disease
- Heart failure, coronary artery disease, myocardial infarction within the last 6 months
- Known allergy to any study treatment
- Pregnancy or lactation period
- Any investigational agent within the past 28 days
- Other previous malignancy within 5 year, except adequately treated in situ cervical cancer, or non-melanoma skin cancer
- Legal incapacity
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00623558
Start Date
April 1 2008
End Date
August 1 2013
Last Update
December 4 2013
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744