Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer

This study has been terminated.
(Low accrual)
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00891904
First received: April 30, 2009
Last updated: January 29, 2014
Last verified: January 2014

April 30, 2009
January 29, 2014
April 2009
July 2011   (final data collection date for primary outcome measure)
Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30 [ Time Frame: Daily while on Treatment ] [ Designated as safety issue: Yes ]
Grade 4-5 toxicity as assessed by NCI CTCAE v.30 [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00891904 on ClinicalTrials.gov Archive Site
  • Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Local and Distant Control [ Time Frame: every 2 months for year one, every 3-4 months for year 2, every 6 months for ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: every 2 months for year one, every 3-4 months for year 2, every 6 months for ] [ Designated as safety issue: No ]
  • Feasibility as assessed according to ability to deliver the entire treatment regimen to 80% of patients [ Designated as safety issue: No ]
  • Local and distant control [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer
A Feasibility Study of Re-irradiation Using Stereotactic Body Radiation Therapy (SBRT) and Cetuximab for Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)

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

PURPOSE: This clinical trial is studying the side effects of radiation therapy given together with cetuximab and to see how well it works in treating patients with recurrent head and neck cancer.

OBJECTIVES:

Primary

  • To assess the toxicity of stereotactic body radiotherapy delivered concurrently with cetuximab in patients with recurrent squamous cell carcinoma of the head and neck.

Secondary

  • To assess the feasibility of delivering this regimen in these patients.
  • To assess the impact of this regimen on local control, distant control, and overall survival of these patients.

OUTLINE: Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5. Patients undergo 1 fraction of stereotactic-body radiotherapy (RT) in week 2. At 4 weeks after RT completion, patients may receive additional cetuximab IV combined with a 28-day chemotherapy regimen, per investigator discretion.

After completion of study treatment, patients are followed every 2 months for 1 year, every 3-4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • Biological: cetuximab
    Given IV
  • Radiation: stereotactic body radiation therapy
    Undergoing Radiotherapy
Experimental: Cetuximab
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5
Interventions:
  • Biological: cetuximab
  • Radiation: stereotactic body radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
Not Provided
July 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the oral cavity, paranasal sinuses, nasopharynx, larynx, hypopharynx, or oropharynx

    • Medically or surgically inoperable disease or patient refuses surgery
    • Recurrent disease
  • Previously irradiated disease meeting the following criteria:

    • Prior radiotherapy completed > 6 months from re-irradiation
    • Prior radiotherapy in the region of the study cancer that would result in overlap of radiation therapy fields
    • Majority of the recurrent tumor volume (> 50%) received prior radiotherapy dose of 30-75 Gy
  • No distant metastatic disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 60 days after completion of study treatment
  • No prior allergic reaction to study drugs

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior surgical resection of the recurrent primary tumor and/or regional lymphatics
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00891904
CDR0000640992, RPCI-I-143108
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
Not Provided
Principal Investigator: Anurag K. Singh, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
January 2014

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