Sunitinib, Cetuximab, and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck

Stopped early · Phase 1

Conditions studied: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Salivary Gland Squamous Cell Carcinoma, Stage III Salivary Gland Cancer, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage III Verrucous Carcinoma of the Larynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IV Salivary Gland Cancer, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IV Verrucous Carcinoma of the Larynx, Stage IV Verrucous Carcinoma of the Oral Cavity, Tongue Cancer, Untreated Metastatic Squamous Neck Cancer With Occult Primary

In brief

This phase I trial is studying the side effects and best dose of sunitinib when given together with cetuximab and radiation therapy in treating patients with locally advanced or recurrent squamous cell carcinoma of the head and neck. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving sunitinib together with cetuximab and radiation therapy may kill more tumor cells.

Key facts

Study ID

NCT00906360

Run by

National Cancer Institute (NCI)

People needed

36

Starts

2008-07-01

Last updated by the study team

2013-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck, meeting any of the following criteria:
• Recurrent disease
• Second primary locoregional recurrence* with no clinically measurable distant disease
• Poor prognosis non-metastatic head and neck carcinoma (M0)
• Must have undergone radiotherapy as a component of prior treatment
• Not a candidate for surgical resection with curative intent
• Patients with high-risk features at resection or following resection for recurrence are eligible
• Must have locoregional tumor amenable to radiotherapy or reirradiation with curative intent
• Entire gross tumor recurrence volume must be able to be treated without exceeding a cumulative spinal cord dose of 50 Gy
• Unresected tumors must be measurable according to RECIST
• No known brain metastases
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Life expectancy > 12 weeks
• WBC ≥ 3,000/mm\^³
• ANC > 1,500/mm³
• Platelet count > 100,000/mm³
• Total bilirubin < 1.5 times upper limit of normal (ULN)
• INR and PTT ratio < 1.5
• AST and ALT ≤ 2.5 times ULN
• Creatinine normal OR creatinine clearance > 60 mL/min
• Urine protein no more than trace
• Hematocrit ≥ 28%
• Hemoglobin ≥ 9 g/dL
• QTc < 500 msec
• Not pregnant or nursing

Where it is running

• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Evanston CCOP-NorthShore University HealthSystem — Evanston, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Illinois CancerCare-Peoria — Peoria, Illinois, United States
• Central Illinois Hematology Oncology Center — Springfield, Illinois, United States
• Fort Wayne Medical Oncology and Hematology Inc - State Boulevard — Fort Wayne, Indiana, United States
• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
• University of Michigan University Hospital — Ann Arbor, Michigan, United States
• Saint John's Mercy Medical Center — St Louis, Missouri, United States
• Froedtert and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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