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Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00462735
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Information provided by (Responsible Party):
Johnny Kao, Icahn School of Medicine at Mount Sinai

Brief 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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Cancer of the Pharynx Cancer of the Larynx Nose Neoplasms Paranasal Sinus Neoplasms Cancer of the Oral Cavity Drug: Cetuximab Drug: Hydroxyurea Drug: Fluorouracil Procedure: radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Concomitant Fluorouracil, Hydroxyurea, Cetuximab and Hyperfractionated Intensity Modulated Radiation Therapy for Locally Advanced Head and Neck Cancer
Study Start Date : February 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Advanced Head and Neck Cancer
Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck
Drug: Cetuximab
250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients

Drug: Hydroxyurea
500 mg orally every 12 hours with the morning dose administered 2 hours before radiation

Drug: Fluorouracil
continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours

Procedure: radiotherapy

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.

Primary Outcome Measures :
  1. Llocoregional Recurrence [ Time Frame: 2 years ]
    Percentage of Participants with Loco-regional recurrence.

  2. Survival [ Time Frame: 2 years ]
    Overall Survival - Percentage of Participants who survived Disease-Free Survival - measured from the initiation of nonsurgical treatment to either the last follow-up, disease progression, or death using intent-to-treat methodology

Secondary Outcome Measures :
  1. Long- Term Toxicity [ Time Frame: 2 years ]
    Grade 3 toxicities events

  2. UW-QOLR: Quality of Life Score [ Time Frame: 2 years ]
    University of Washington Quality of Life (UW-QOLR) questionnaire - covers 12 domains - pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder function, taste, saliva, mood and anxiety. Each domain have between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response and reported as one composite score from 0 (worst) to 100 (best).

  3. Distant Metastases [ Time Frame: 2 years ]
    Percentage of participants who did not have distant control

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462735

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United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Johnny Kao
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Principal Investigator: Johnny Kao, MD Icahn School of Medicine at Mount Sinai
Publications of Results:
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Responsible Party: Johnny Kao, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00462735    
Other Study ID Numbers: GCO 06-1155
First Posted: April 19, 2007    Key Record Dates
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018
Last Verified: February 2018
Keywords provided by Johnny Kao, Icahn School of Medicine at Mount Sinai:
Cancer of the Nasal Cavity
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Laryngeal Neoplasms
Pharyngeal Neoplasms
Paranasal Sinus Neoplasms
Nose Neoplasms
Neoplasms by Site
Otorhinolaryngologic Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Nose Diseases
Paranasal Sinus Diseases
Skull Neoplasms
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs