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

Phase 2

Completed

• Conditions: Head and Neck Neoplasm
• Interventions: Drug: Cetuximab; Drug: Docetaxel; Drug: Cisplatin

• Registration Number: NCT00623558
• Lead Sponsor: Seoul National University Hospital

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 available

Study Timeline

• Study First Submitted: 2008-02-17
• Study First Submitted QC: 2008-02-17
• Study First Posted: 2008-02-26
• Study Start: 2008-04
• Primary Completion: 2012-11
• Status Verified: 2013-04
• Study Completion: 2013-08
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Docetaxel	Docetaxel+CDDP+Cetuximab
2	Cisplatin	Docetaxel+CDDP+Cetuximab
1	Docetaxel	Docetaxel+CDDP
1	Cisplatin	Docetaxel+CDDP
2	Cetuximab	Docetaxel+CDDP+Cetuximab

Primary Outcome Measures

Name	Time	Method
Response rate	after induction treatment

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of