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

Primary Purpose

Head and Neck Neoplasm

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cetuximab
Docetaxel
Cisplatin
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasm focused on measuring head and neck neoplasm, cetuximab, docetaxel, cisplatin, radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Docetaxel+CDDP

Docetaxel+CDDP+Cetuximab

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Full Information

First Posted
February 17, 2008
Last Updated
December 3, 2013
Sponsor
Seoul National University Hospital
Collaborators
Clinical Research Center for Solid Tumor, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00623558
Brief Title
Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)
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 Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Clinical Research Center for Solid Tumor, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasm
Keywords
head and neck neoplasm, cetuximab, docetaxel, cisplatin, radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Docetaxel+CDDP
Arm Title
2
Arm Type
Experimental
Arm Description
Docetaxel+CDDP+Cetuximab
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
400 mg/m2 first dose, then 250 mg/m2 weekly for 9 weeks
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)
Primary Outcome Measure Information:
Title
Response rate
Time Frame
after induction treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Seog Heo, Prof.
Organizational Affiliation
Clinical Research Center for Solid Tumors, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26304911
Citation
Lee KW, Koh Y, Kim SB, Shin SW, Kang JH, Wu HG, Sung MW, Keam B, Kim DW, Kim TM, Kim KH, Kwon TK, Hah JH, Kim IA, Ahn SH, Yoon DH, Lee SW, Kim SY, Nam SY, Jung KY, Baek SK, Hong SH, Lee SH, Heo DS. A Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer. Oncologist. 2015 Oct;20(10):1119-20. doi: 10.1634/theoncologist.2015-0208. Epub 2015 Aug 24.
Results Reference
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Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)

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