Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)

This study has been completed.
Clinical Research Center for Solid Tumor, Korea
Information provided by (Responsible Party):
Dae Seog Heo, Seoul National University Hospital Identifier:
First received: February 17, 2008
Last updated: December 3, 2013
Last verified: April 2013

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.

Condition Intervention Phase
Head and Neck Neoplasm
Drug: Cetuximab
Drug: Docetaxel
Drug: Cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Response rate [ Time Frame: after induction treatment ] [ Designated as safety issue: Yes ]

Enrollment: 92
Study Start Date: April 2008
Study Completion Date: August 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Drug: Docetaxel
75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)
Drug: Cisplatin
75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)
Experimental: 2
Drug: Cetuximab
400 mg/m2 first dose, then 250 mg/m2 weekly for 9 weeks
Drug: Docetaxel
75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)
Drug: Cisplatin
75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00623558

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Clinical Research Center for Solid Tumor, Korea
Principal Investigator: Dae Seog Heo, Prof. Clinical Research Center for Solid Tumors, Korea
  More Information

No publications provided

Responsible Party: Dae Seog Heo, Professor, Seoul National University Hospital Identifier: NCT00623558     History of Changes
Other Study ID Numbers: CRCST-L0002
Study First Received: February 17, 2008
Last Updated: December 3, 2013
Health Authority: Korea: Institutional Review Board
Korea: Korean Food and Drug Administration

Keywords provided by Seoul National University Hospital:
head and neck neoplasm

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators processed this record on February 26, 2015