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

Sponsored by:	Centre Oscar Lambret
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00738868

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	Drug: cetuximab Procedure: stereotactic radiation therapy	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer Salivary Gland Disorders

Drug Information available for: Cetuximab

U.S. FDA Resources

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

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
Estimated Primary Completion Date:	December 2008 (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	Recruiting
Lille, France, 59020
Contact: Contact Person 33-32-029-5959

Sponsors and Collaborators

Centre Oscar Lambret

Investigators

Study Chair:

Eric Lartigau, MD, PhD

Centre Oscar Lambret

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000589673, COL-CKNO-RERT, COL-0705, INCA-RECF0629
Study First Received:	August 20, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00738868
Health Authority:	Unspecified

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

Study placed in the following topic categories:

Epidermoid carcinoma
Nasopharyngeal carcinoma
Squamous cell carcinoma
Head and Neck Neoplasms
Cetuximab
Carcinoma, squamous cell

Laryngeal carcinoma
Hypopharyngeal cancer
Carcinoma, Squamous Cell
Salivary Gland Diseases
Recurrence
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009