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

This study has been completed.
Sponsor:
Collaborator:
Clinical Research Center for Solid Tumor, Korea
Information provided by (Responsible Party):
Dae Seog Heo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00623558
First received: February 17, 2008
Last updated: December 3, 2013
Last verified: April 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


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 ]

Enrollment: 92
Study Start Date: April 2008
Study Completion Date: August 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Dae Seog Heo, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00623558     History of Changes
Other Study ID Numbers: CRCST-L0002
Study First Received: February 17, 2008
Last Updated: December 3, 2013
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

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Docetaxel
Cetuximab
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014