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



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:4/28/2018
Start Date:December 2008
End Date:May 2016

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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

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.

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.

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
We found this trial at
4
sites
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Dallas, TX
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