Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer
Condition: Head and Neck Cancer; Cancer of the Pharynx; Cancer of the Larynx; Nose Neoplasms; Paranasal Sinus Neoplasms; Cancer of the Oral Cavity
MeSH terms: Neoplasms; Head and Neck Neoplasms; Laryngeal Neoplasms; Paranasal Sinus Neoplasms; Pharyngeal Neoplasms; Nose Neoplasms
Intervention: Cetuximab; Hydroxyurea; Fluorouracil; radiotherapy
Intervention description: 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients; 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation; continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours; Radiotherapy was administered at 1.5 Gy per fraction twice daily with treatments separated by at least 6 hours on Days 1 through 5 on an alternating week schedule.
Radiation was delivered with intensity-modulated radiation therapy (IMRT) planning for all patients.
Intervention MeSH terms: Fluorouracil; Cetuximab; Hydroxyurea
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer of the Nasal Cavity

Summary:

      For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences
      and for many patients, improves survival. While combined cisplatin and radiation or cetuximab
      and radiation is more effective than radiation alone, approximately 50% of these patients
      will still recur. A more aggressive approach may be needed for these patients to prevent
      recurrence and death. The strategy of using multiple chemotherapy drugs with radiation given
      twice a day has been tested at Mount Sinai and University of Chicago. Approximately 80% of
      patients are cured with this strategy. While cure rates are higher than standard chemotherapy
      and radiation and the treatment is tolerable, side effects during treatment are common. We
      propose replacing a chemotherapy drug with a less toxic, targeted therapy called cetuximab.
      Our goal is to reduce toxicity while maintaining or improving cure rates for these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  Histologically or cytologically confirmed diagnosis of squamous cell or poorly
             differentiated carcinomas of the head and neck or lymphoepithelioma

          -  No prior chemotherapy or radiotherapy

          -  Prior surgical therapy will consist only of incisional or excisional biopsy, and organ
             sparing procedures such as debulking of airway-compromising tumors or neck dissection
             in a patient with an existing primary tumor

          -  Karnofsky performance status of >= 70%

          -  Intact organ and bone marrow function

          -  Obtained informed consent

        Exclusion Criteria:

          -  Demonstration of metastatic disease (i.e. M1 disease).

          -  Patients with a history of severe allergic reaction to docetaxel or other drugs
             formulated with polysorbate 80. History of allergic reactions attributed to compounds
             of similar chemical or biologic composition to cisplatin, 5-fluorouracil, or
             hydroxyurea.

          -  Other coexisting malignancies or malignancies diagnosed within the previous 3 years
             with the exception of basal cell carcinoma, cervical cancer in situ, and other treated
             malignancies with no evidence of disease for at least 3 years.

          -  Prior surgical therapy other than incisional or excisional biopsy and organ-sparing
             procedures such as debulking of airway-compromising tumors or neck dissection in a
             patient with an unknown primary tumor. Any non-biopsy procedure must have taken place
             less than 3 months from initiating protocol treatment.

          -  Incomplete healing from previous surgery

          -  Pregnancy or breast feeding (men and women of child-bearing potential are eligible but
             must consent to using effective contraception during therapy and for at least 3 months
             after completing therapy)

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure (CHF), unstable angina pectoris,
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements

          -  Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any
             history of clinically significant CHF are excluded. The exclusion of patients with
             active coronary artery disease will be at the discretion of the attending physician.

          -  Uncontrolled active infection unless curable with treatment of their cancer.