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

August 20, 2008
May 12, 2011
October 2007
May 2011   (final data collection date for primary outcome measure)
Percentage of patients with nonprogressive disease at 12 months according to RECIST criteria [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00738868 on ClinicalTrials.gov Archive Site
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Cetuximab and Stereotactic Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery
Re-irradiation and Stereotactic Cetuximab in Patients With Recurrent Carcinoma of the Head and Neck

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Primary Purpose: Treatment
Head and Neck Cancer
  • Biological: cetuximab
  • Radiation: stereotactic body radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
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May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00738868
CDR0000589673, COL-CKNO-RERT, COL-0705, INCA-RECF0629
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Centre Oscar Lambret
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Study Chair: Eric Lartigau, MD, PhD Centre Oscar Lambret
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP