Chemotherapy, Radiation Therapy, and Cetuximab in Treating Patients With the Head and Neck Cancer

November 20, 2014 updated by: Centre Antoine Lacassagne

Phase II Study Evaluating Radiotherapy-chemotherapy and Cetuximab in Patients With Histologically Proven Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx, or Larynx and With a Poor Prognosis After Complete Surgical Resection

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy together with radiation therapy and cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well chemotherapy given together with radiation therapy and cetuximab works in treating patients with head and neck cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Evaluate disease-free survival at 2 years in patients with poor prognosis squamous cell carcinoma of the head and neck treated with chemoradiotherapy and cetuximab after complete surgical resection.

Secondary

  • Evaluate quality of life.
  • Evaluate tolerability.
  • Evaluate overall survival.
  • Analyze germinal polymorphisms.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV on day 1. Treatment with cetuximab repeats every week for up to 8 courses. Patients also receive cisplatin IV on day 8. Treatment with cisplatin repeats every 3 weeks for up to 3 courses. Patients undergo concurrent radiotherapy 5 times a week for 7 weeks beginning on day 8.

After completion of study treatment, patients are followed at 1 month and then every 3 months for 2 years.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06189
        • Centre Antoine Lacassagne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
  • Must have undergone complete macroscopic resection

  • Presence of ≥ 1 of the following poor prognostic factors after complete resection:

    • Incomplete microscopic resection and N+
    • Complete microscopic resection and > 2 N+
    • Vascular and/or lymphatic embolism
    • At least 2 peripheral nerve invasions
    • Positive surgical margins and pT4 lesion
  • No metastases

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • ANC > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 9 g/dL
  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • Serum creatinine < 1.25 times ULN and/or creatinine clearance > 55 mL/min
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No serious and disabling cardiac, renal, hepatic, or respiratory failure
  • No coronary artery disease or myocardial infarction within the past year
  • No uncontrolled cardiac arrhythmia
  • Other active and serious diseases allowed at discretion of the investigator
  • No known severe allergy to cisplatin, cetuximab, or any of their excipients
  • No other malignant disease diagnosed within the past 5 years except for basal cell carcinoma of the skin or in situ cervical cancer
  • No psychological, familial, social, or geographic situations that preclude clinical follow up

PRIOR CONCURRENT THERAPY:

  • No prior treatment (except surgery) for this cancer or another head and neck cancer
  • At least 3 months since prior treatment with an investigational agent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cetuximab
Radiation: radiation therapy
Drug: cisplatin
Biological: cetuximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival at 2 years
Time Frame: 2 YEARS
2 YEARS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Antoine Lacassagne

Investigators

  • Principal Investigator: Philippe Follana, Centre Antoine Lacassagne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 2, 2009

First Submitted That Met QC Criteria

April 2, 2009

First Posted (Estimate)

April 3, 2009

Study Record Updates

Last Update Posted (Estimate)

November 21, 2014

Last Update Submitted That Met QC Criteria

November 20, 2014

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000633474
  • CALACASS-AACER
  • MERCK-CALACASS-AACER
  • INCA-RECF0623
  • EUDRACT-2007-004384-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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