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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

crude survival

Outcome Description:

1-year crude survival

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Lucien A. Nedzi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Simmons Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000632295

NCT ID:

NCT00833261

Start Date:

December 2008

Completion Date:

December 2018

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Medical College of WisconsinMilwaukee, Wisconsin  53226
University Hospitals of ClevelandCleveland, Ohio  44106
Baylor Research InstituteDallas, Texas  75246
University of Texas Southwestern Medical Center - DallasDallas, Texas  75390