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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00623558
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : December 4, 2013
Sponsor:
Collaborator:
Clinical Research Center for Solid Tumor, Korea
Information provided by (Responsible Party):
Dae Seog Heo, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasm Drug: Cetuximab Drug: Docetaxel Drug: Cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : April 2008
Primary Completion Date : November 2012
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Docetaxel+CDDP
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
Docetaxel+CDDP+Cetuximab
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)



Primary Outcome Measures :
  1. Response rate [ Time Frame: after induction treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623558


Locations
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
Investigators
Principal Investigator: Dae Seog Heo, Prof. Clinical Research Center for Solid Tumors, Korea

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dae Seog Heo, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00623558     History of Changes
Other Study ID Numbers: CRCST-L0002
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: April 2013

Keywords provided by Dae Seog Heo, Seoul National University Hospital:
head and neck neoplasm
cetuximab
docetaxel
cisplatin
radiotherapy

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Docetaxel
Cisplatin
Cetuximab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action