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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00833261
First received: January 30, 2009
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer.


Condition Intervention Phase
Head and Neck Cancer
Drug: cetuximab
Drug: cisplatin
Radiation: intensity-modulated radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Multi-Center Study of Concomitant Cetuximab and Cisplatin With Re-Irradiation Using Intensity-Modulated Radiotherapy in Patients With Recurrent Squamous Cell Carcinoma of the Head-and-Neck

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • crude survival [ Time Frame: one year ] [ Designated as safety issue: No ]
    1-year crude survival


Secondary Outcome Measures:
  • progression-free survival and local-regional progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    1-year progression-free survival and local-regional progression

  • acute and late toxicities [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    Incidence rate of acute and late toxicities

  • disease progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Pattern of disease progression

  • Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    tumor response


Enrollment: 50
Study Start Date: December 2008
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: arm one
Cetuximab, Cisplatin, and Radiation Therapy
Drug: cetuximab
cetuximab
Drug: cisplatin
cisplatin
Radiation: intensity-modulated radiation therapy
IMRT
Other Name: IMRT

Detailed Description:

OBJECTIVES:

Primary

  • To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated radiotherapy improves the overall survival of patients with recurrent squamous cell carcinoma of the head and neck.

Secondary

  • To determine the progression-free survival and local-regional progression in these patients.
  • To identify and estimate the incidence rate of acute and late toxicities associated with this treatment regimen.
  • To determine the pattern of disease progression in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated radiotherapy once daily 5 days a week in weeks 2-7.

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

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive tract
  • Recurrent disease or second primary SCC

    • Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence)
    • Majority (≥ 75%) of the recurrent tumor must be in areas previously irradiated to ≥ 45 Gy
    • More than one recurrence allowed provided the first recurrence occurred > 6 months after the completion of prior radiotherapy
  • Unresectable disease OR has high-risk features after resection (e.g., positive margins and/or extracapsular extension)

    • No signs of carotid exposure
  • No primary nasopharyngeal or salivary gland tumor
  • Equivocal pulmonary nodes on chest CT scan allowed provided they are < 1 cm, cannot be safely biopsied, or are negative on PET scan
  • No distant metastasis

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • ANC ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
  • Bilirubin < 1.5 mg/dL
  • AST or ALT < 2 times upper limit of normal
  • Creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to submit prior radiotherapy records to assure that the spinal cord tolerance is not exceeded
  • No active cardiac disease, including any of the following:

    • Unstable angina
    • Uncontrolled hypertension
    • Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty)
    • Uncontrolled arrhythmia
    • Congestive heart failure
    • At least 3 heart-related hospitalizations within the past year
  • No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year
  • No concurrent medical illness that would impair patient tolerance to therapy or limit survival
  • No other invasive malignancy within the past 2 years
  • No pre-existing peripheral sensory neuropathy ≥ grade 2
  • No prior severe infusion reaction to a monoclonal antibody
  • No prisoners or individuals who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior surgery
  • Prior cisplatin and cetuximab allowed
  • At least 6 months since prior radiotherapy or chemotherapy
  • No prior radiotherapy > 75 Gy
  • No prior chemotherapy for recurrent head and neck cancer

    • Prior chemotherapy as a component of the primary treatment allowed
  • No prior combination cisplatin, cetuximab, and radiotherapy for recurrent head and neck cancer

    • Patients with a new primary head and neck cancer whose prior primary head and neck cancer was treated with concurrent cisplatin, cetuximab, and radiotherapy are eligible provided it has been > 6 months since treatment
  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: NCT00833261

Locations
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Texas
University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Baylor Research Institute
Dallas, Texas, United States, 75204
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Lucien A. Nedzi, MD Simmons Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00833261     History of Changes
Other Study ID Numbers: CDR0000632295, SCCC-04308, CA 225314, 112008-004
Study First Received: January 30, 2009
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent verrucous carcinoma of the oral cavity
recurrent metastatic squamous neck cancer with occult primary
recurrent squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
tongue cancer

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
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014