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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 Wisconsin Milwaukee, Wisconsin  53226
University Hospitals of Cleveland Cleveland, Ohio  44106
Baylor Research Institute Dallas, Texas  75246
University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390