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OpenTrials
Completed

NCT Number: NCT00623558

Cetuximab as Induction Treatment in 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.

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Key information

Conditions

Head and Neck Neoplasm Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetuximab

Drug

400 mg/m2 first dose, then 250 mg/m2 weekly for 9 weeks

docetaxel

Drug

75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)

Cisplatin

Drug

75 mg/m2, day 1 of every 3 weeks for 9 weeks (3 cycles)

Primary outcomes

  1. Response rate

    Time frame: after induction treatment

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Clinical Research Center for Solid Tumor, Korea

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Feb 26, 2008
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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