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
  Purpose

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.


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30 [ Time Frame: Daily while on Treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2
Study Start Date: April 2009
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5
Biological: cetuximab
Given IV
Radiation: stereotactic body radiation therapy
Undergoing Radiotherapy

Detailed Description:

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.

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891904

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Anurag K. Singh, MD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00891904     History of Changes
Other Study ID Numbers: CDR0000640992, RPCI-I-143108
Study First Received: April 30, 2009
Results First Received: January 29, 2014
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2014