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

This study is currently recruiting participants.

Verified by Seoul National University Hospital, October 2008

Sponsors and Collaborators:	Seoul National University Hospital Clinical Research Center for Solid Tumor, Korea
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00623558

Purpose

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	Intervention	Phase
Head and Neck Neoplasm	Drug: Cetuximab Drug: Docetaxel Drug: Cisplatin	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Docetaxel Cisplatin Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

Response rate [ Time Frame: after induction treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	92
Study Start Date:	April 2008
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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)
2: Experimental 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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623558

Locations

Korea, Republic of
Seoul National University Hospital	Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Se-Hoon Lee, Prof. +82-2-2072-0832 shlee119@snu.ac.kr

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

More Information

Responsible Party:	Clinical Research Center for Solid Tumor, Korea ( Dae Seog Heo, Professor )
Study ID Numbers:	CRCST-L0002
Study First Received:	February 17, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00623558
Health Authority:	Korea: Institutional Review Board; Korea: Korean Food and Drug Administration

Keywords provided by Seoul National University Hospital:

head and neck neoplasm
cetuximab
docetaxel
cisplatin
radiotherapy

Study placed in the following topic categories:

Docetaxel
Epidermoid carcinoma
Cisplatin
Squamous cell carcinoma
Head and Neck Neoplasms
Cetuximab

Carcinoma, squamous cell
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Carcinoma, squamous cell of head and neck
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Radiation-Sensitizing Agents

Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009