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

December 3, 2013 updated by: Dae Seog Heo, Seoul National University Hospital

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: 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)
Drug: Cetuximab
400 mg/m2 first dose, then 250 mg/m2 weekly for 9 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: after induction treatment
after induction treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Clinical Research Center for Solid Tumor, Korea

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

February 17, 2008

First Submitted That Met QC Criteria

February 17, 2008

First Posted (Estimate)

February 26, 2008

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRCST-L0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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