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Status:

COMPLETED

Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck

Lead Sponsor:

Radiation Therapy Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

NRG Oncology

Conditions:

Head and Neck Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, suc...

Detailed Description

OBJECTIVES: Primary * Compare disease-free survival of patients with resected stage III or IV squamous cell carcinoma or lymphoepithelioma of the head and neck treated with adjuvant cetuximab in com...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed squamous cell carcinoma of the head and neck meeting the following criteria:
  • Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding lip, nasopharynx, or sinuses)
  • Gross total resection must be completed within 7 weeks of randomization, with pathology demonstrating one or more of the following risk factors:
  • Histologic extracapsular nodal extension
  • Histologic involvement of ≥ 2 regional lymph nodes
  • Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual.
  • Tonsillar cancer patients who undergo transoral excision of all gross tumor are eligible provided extracapsular nodal extension or involvement of ≥ 2 regional lymph nodes is histologically confirmed
  • American Joint Committee on Cancer (AJCC) pathological stage III or IV
  • No evidence of distant metastases
  • No synchronous or concurrent head and neck primary tumors
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • Zubrod 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 2,000/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin \> 8.0 g/dL
  • Hepatic
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), and alkaline phosphatase meeting 1 of the following parameters:
  • Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN
  • Renal
  • Creatinine ≤ 1.5 mg/dL
  • Cardiovascular
  • No unstable angina
  • No uncontrolled hypertension
  • No myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass surgery or percutaneous transluminal coronary angioplasty)
  • No uncontrolled arrhythmia
  • No congestive heart failure
  • No more than 2 heart-related hospitalizations within the past year
  • No other active cardiac disease
  • Pulmonary
  • No more than 2 hospitalizations for chronic obstructive pulmonary disease within the past year
  • Neurologic
  • No pre-existing peripheral neuropathy ≥ grade 2
  • No uncontrolled seizure disorder
  • No active neurological disease
  • Other
  • No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No prior anti-epidermal growth factor receptor antibody therapy
  • Chemotherapy
  • More than 3 years since prior cytotoxic chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • No prior head and neck radiotherapy
  • Surgery
  • See Disease Characteristics
  • Other
  • No prior tyrosine kinase inhibitor therapy

Exclusion

    Key Trial Info

    Start Date :

    April 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2016

    Estimated Enrollment :

    238 Patients enrolled

    Trial Details

    Trial ID

    NCT00084318

    Start Date

    April 1 2004

    End Date

    December 1 2016

    Last Update

    December 12 2018

    Active Locations (160)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 40 (160 locations)

    1

    University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, United States, 35294

    2

    Mobile Infirmary Medical Center

    Mobile, Alabama, United States, 36652-2144

    3

    Arizona Oncology Services Foundation

    Phoenix, Arizona, United States, 85013

    4

    Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn

    Scottsdale, Arizona, United States, 85251