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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00623558

Collaborator

Clinical Research Center for Solid Tumor, Korea (Other)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Neoplasm	Drug: Cetuximab Drug: Docetaxel Drug: Cisplatin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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)

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

Response rate [after induction treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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