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Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx
This study is ongoing, but not recruiting participants.
First Received: January 28, 2000   Last Updated: May 30, 2009   History of Changes
Sponsor: University of Alabama at Birmingham
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004227
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if radiation therapy is more effective with or without cetuximab for cancer of the oropharynx, hypopharynx, or larynx.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without cetuximab in treating patients who have stage III or stage IV cancer of the oropharynx, hypopharynx, or larynx.


Condition Intervention Phase
Head and Neck Cancer
 Biological: cetuximab
Procedure: conventional surgery
Radiation: radiation therapy
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Randomized Phase III Trial to Compare Radiation Therapy Alone With Radiation Therapy and Concomitant Anti-EGFr Antibody (C225) for Locally Advanced Squamous Cell Carcinomas of the Head and Neck

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer
Drug Information available for: Cetuximab
U.S. FDA Resources

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

Study Start Date: May 2000
Detailed Description:

OBJECTIVES:

  • Compare the rate of locoregional disease control maintained for 1 year in patients with advanced squamous cell carcinoma of the oropharynx, hypopharynx, or larynx treated with radiotherapy with or without concurrent cetuximab.
  • Compare the response rates, progression-free survival and overall survival rates, and quality of life in patients treated with these regimens.
  • Compare acute and late toxicity of these regimens in these patients.
  • Determine tumor epidermal growth factor receptor levels in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by Karnofsky performance status (60-80% vs 90-100%), nodal stage (N0 vs N+), tumor stage (T1-3 vs T4), and radiotherapy schedule (concurrent boost vs once daily vs twice daily).

Patients are randomized to 1 of 2 treatment arms:

  • Arm I: Patients undergo radiotherapy beginning on day 1. Patients are assigned to 1 of 3 radiotherapy groups:

    • Group 1: Patients undergo concurrent boost radiotherapy comprised of radiotherapy once daily 5 days a week for 3.5 weeks followed by radiotherapy twice daily 5 days a week for 2.5 weeks.
    • Group 2: Patients undergo radiotherapy once daily 5 days a week for 7 weeks.
    • Group 3: Patients undergo radiotherapy twice daily 5 days a week for 6-6.5 weeks.
  • Arm II: Patients receive a test dose of cetuximab IV over 10 minutes on day 1. Patients who do not experience grade 4 anaphylactic reaction receive a loading dose of cetuximab IV over 2 hours beginning 30 minutes after completion of test dose. Patients receive maintenance cetuximab IV over 1 hour on day 8. Maintenance cetuximab repeats every week for 7 courses. Beginning on day 8, patients undergo radiotherapy as in arm I concurrently with maintenance cetuximab. There must be an hour interval between the completion of cetuximab infusion and the start of any radiotherapy.

Patients with more than N1 neck disease at initial presentation undergo neck dissection 4-8 weeks after the completion of radiotherapy.

Quality of life is assessed before initiation of study therapy, at 8 weeks, and then every 4 months for 1 year.

Patients are followed at 8 weeks, every 4 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 416 patients (208 per arm) will be accrued for this study within approximately 5 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically proven advanced squamous cell carcinoma of the oropharynx, hypopharynx, or larynx

    • Stage III OR
    • Stage IV without distant metastases
  • Measurable disease
  • Tumor tissue available for immunohistochemical assay of epidermal growth factor receptor expression

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 1 year

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT and SGPT no greater than 2 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 50 mL/min
  • Calcium normal

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Medically able to withstand a course of definitive radiotherapy
  • No medical or psychologic condition that would preclude informed consent or compliance
  • No other malignancy within the past 3 years except basal cell skin cancer or preinvasive carcinoma of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior cetuximab or other murine monoclonal antibody

Chemotherapy:

  • At least 3 years since prior systemic chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to head and neck
  • No other concurrent radiotherapy

Surgery:

  • No prior surgery for indicator lesion except biopsy
  • Study radiotherapy must not be a part of a postoperative regimen after primary surgical resection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004227

Locations
United States, New Jersey
ImClone Systems, Incorporated
Somerville, New Jersey, United States, 08876
Kimball Medical Center
Lakewood, New Jersey, United States, 08701
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Sponsors and Collaborators
University of Alabama at Birmingham
National Cancer Institute (NCI)
Investigators
Study Chair: James A. Bonner, MD University of Alabama at Birmingham
  More Information

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

Publications:
Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78.
Bonner JA, Harari PM, Giralt J, et al.: The relationship of cetuximab-induced rash and survival in patients with head and neck cancer treated with radiotherapy and cetuximab. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-120, S73, 2005.
Bonner JA, Girald J, Harari PM, et al.: Phase III evaluation of radiation with and without cetuximab for locoregionally advanced head and neck cancer. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-31, S147-8, 2004. Available online. Last accessed February 3, 2005.

Study ID Numbers: CDR0000067468, UAB-9901, IMCL-CP02-9815, NCI-G99-1657
Study First Received: January 28, 2000
Last Updated: May 30, 2009
ClinicalTrials.gov Identifier: NCT00004227     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
 recurrent squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx

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

ClinicalTrials.gov processed this record on November 22, 2009



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