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

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Head and Neck Neoplasm

Treatments: Drug: Cetuximab; Drug: Docetaxel; Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00623558

CRCST-L0002

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

92 participants in 2 patient groups

1

Active Comparator group

Description:

Docetaxel+CDDP

Treatment:

Drug: Docetaxel

Drug: Cisplatin

2

Experimental group

Description:

Docetaxel+CDDP+Cetuximab

Treatment:

Drug: Docetaxel

Drug: Cisplatin

Drug: Cetuximab