NCT00623558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 4, 2013

Status Verified

April 1, 2013

Enrollment Period

4.6 years

First QC Date

February 17, 2008

Last Update Submit

December 3, 2013

Conditions

Head and Neck Neoplasm

Keywords

head and neck neoplasmcetuximabdocetaxelcisplatinradiotherapy

Outcome Measures

Primary Outcomes (1)

  • Response rate

    after induction treatment

Study Arms (2)

1

ACTIVE COMPARATOR

Docetaxel+CDDP

Drug: DocetaxelDrug: Cisplatin

2

EXPERIMENTAL

Docetaxel+CDDP+Cetuximab

Drug: CetuximabDrug: DocetaxelDrug: Cisplatin

Interventions

CetuximabDRUG

400 mg/m2 first dose, then 250 mg/m2 weekly for 9 weeks

2
DocetaxelDRUG

75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)

12
CisplatinDRUG

75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 26304911DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

CetuximabDocetaxelCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Dae Seog Heo, Prof.

    Clinical Research Center for Solid Tumors, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 17, 2008

First Posted

February 26, 2008

Study Start

April 1, 2008

Primary Completion

November 1, 2012

Study Completion

August 1, 2013

Last Updated

December 4, 2013

Record last verified: 2013-04

Locations

KR(1)