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

February 17, 2008
December 3, 2013
April 2008
November 2012   (final data collection date for primary outcome measure)
Response rate [ Time Frame: after induction treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00623558 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Neoplasm
  • 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)
  • Active Comparator: 1
    Docetaxel+CDDP
    Interventions:
    • Drug: Docetaxel
    • Drug: Cisplatin
  • Experimental: 2
    Docetaxel+CDDP+Cetuximab
    Interventions:
    • Drug: Cetuximab
    • Drug: Docetaxel
    • Drug: Cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
August 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00623558
CRCST-L0002
No
Dae Seog Heo, Seoul National University Hospital
Seoul National University Hospital
Clinical Research Center for Solid Tumor, Korea
Principal Investigator: Dae Seog Heo, Prof. Clinical Research Center for Solid Tumors, Korea
Seoul National University Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP