Cetuximab and Stereotactic Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00738868
First received: August 20, 2008
Last updated: May 12, 2011
Last verified: July 2009
  Purpose

RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving cetuximab together with stereotactic radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how giving cetuximab together with stereotactic radiation therapy works in treating patients with recurrent squamous cell carcinoma of the head and neck cancer that cannot be removed by surgery.


Condition Intervention Phase
Head and Neck Cancer
Biological: cetuximab
Radiation: stereotactic body radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Re-irradiation and Stereotactic Cetuximab in Patients With Recurrent Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Percentage of patients with nonprogressive disease at 12 months according to RECIST criteria [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: October 2007
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Evaluate local control at 12 months in patients with recurrent squamous cell carcinoma of the head and neck treated with cetuximab and stereotactic radiotherapy.

Secondary

  • Determine the incidence of cutaneous toxicity.
  • Assess the care and development of skin reactions.
  • Determine the quality of life of patients treated with this drug.
  • Determine tumor response at 2 months.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV once weekly for 5 weeks. Patients undergo stereotactic radiotherapy 3 times weekly during weeks 2 and 3.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the head and neck

    • Unresectable disease
    • Recurrent disease
  • No metastatic disease
  • Disease in previously irradiated area must be proven by biopsy or imaging

    • At least 3 months between prior radiotherapy and diagnosis of recurrent disease
  • Surgery or brachytherapy must be possible
  • Measurable or evaluable disease by RECIST criteria
  • No available curative therapy

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Not pregnant or nursing
  • No psychological, familial, social, or geographical reasons that would make monitoring the patient impossible
  • No other malignant disease

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent participation in another clinical study of an experimental drug
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738868

Locations
France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Study Chair: Eric Lartigau, MD, PhD Centre Oscar Lambret
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00738868     History of Changes
Other Study ID Numbers: CDR0000589673, COL-CKNO-RERT, COL-0705, INCA-RECF0629
Study First Received: August 20, 2008
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
recurrent verrucous carcinoma of the oral cavity
stage III verrucous carcinoma of the oral cavity
recurrent squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent salivary gland cancer
salivary gland squamous cell carcinoma
stage III salivary gland cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014