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

Head and Neck Neoplasm Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623558
• Other study ID #: CRCST-L0002
• Status: Completed
• Phase: Phase 2
• First received: February 17, 2008
• Last updated: December 3, 2013
• Start date: April 2008
• Est. completion date: August 2013

Study information

• Verified date: April 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardKorea: Korean Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasm
• Head and Neck Neoplasms

Intervention

Drug:
• Cetuximab
400 mg/m2 first dose, then 250 mg/m2 weekly for 9 weeks
• Docetaxel
75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)
• Cisplatin
75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Clinical Research Center for Solid Tumor, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		after induction treatment	Yes