Cetuximab as Induction Treatment in Head and Neck Squamou... | NCT00623558

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

NCT00623558

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Dec 4, 2013Estimated

Enrollment

92Actual

Phase

Phase 2

Conditions

Head and Neck Neoplasm

Interventions

Cetuximab
Docetaxel
Cisplatin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Nov 2012Actual

Completion Date

Aug 2013Actual

First Submitted Date

Feb 17, 2008

First Submission Date that Met QC Criteria

Feb 17, 2008

First Posted Date

Feb 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2013

Last Update Posted Date

Dec 4, 2013Estimated

Name	Class
Clinical Research Center for Solid Tumor, Korea	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Docetaxel+CDDP	Drug: Docetaxel Drug: Cisplatin
2	Experimental	Docetaxel+CDDP+Cetuximab	Drug: Cetuximab Drug: Docetaxel Drug: Cisplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cetuximab	Drug	400 mg/m2 first dose, then 250 mg/m2 weekly for 9 weeks	2

Measure	Description	Time Frame
Response rate		after induction treatment

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dae Seog Heo, Prof.	Clinical Research Center for Solid Tumors, Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26304911	Derived	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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins