A Randomized, Multicenter, Open Phase II Study of Cetuximab With Docetaxel, Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Neoplasm
Both
Head and Neck Neoplasm
Trial Information
A Randomized, Multicenter, Open Phase II Study of Cetuximab With Docetaxel, Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
after induction treatment
Safety Issue:
Yes
Principal Investigator
Dae Seog Heo, Prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Clinical Research Center for Solid Tumors, Korea
Authority:
Korea: Institutional Review Board
Study ID:
CRCST-L0002
NCT ID:
NCT00623558
Start Date:
April 2008
Completion Date:
August 2013
Related Keywords:
- Head and Neck Neoplasm
- head and neck neoplasm
- cetuximab
- docetaxel
- cisplatin
- radiotherapy
- Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
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