Full Text View
Tabular View
No Study Results Posted
Related Studies
Fluorouracil, Hydroxyurea, Cetuximab and Twice-Daily Intensity Radiation Therapy for Advanced Head and Neck Cancer
This study is currently recruiting participants.
Verified by Mount Sinai School of Medicine, June 2008
First Received: April 18, 2007   Last Updated: June 17, 2008   History of Changes
Sponsor: Mount Sinai School of Medicine
Information provided by: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00462735
  Purpose

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 Intervention 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: chemotherapy
Procedure: radiotherapy
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Study of Concomitant Fluorouracil, Hydroxyurea, Cetuximab and Hyperfractionated Intensity Modulated Radiation Therapy for Locally Advanced Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • locoregional control
  • survival

Secondary Outcome Measures:
  • acute and late toxicity
  • quality of life
  • distant metastases

Estimated Enrollment: 30
Study Start Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462735

Contacts
Contact: Johnny Kao, MD 212-241-7503 Johnny.kao@mountsinai.org
Contact: Stuart Packer, MD 212-241-8617 stuart.packer@Mountsinai.org

Locations
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Johnny Kao, MD     212-241-7503     Johnny.kao@mountsinai.org    
Contact: Stuart Packer, MD     212-241-8617     stuart.packer@Mountsinai.org    
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Johnny Kao, MD Mount Sinai School of Medicine
  More Information

No publications provided

Study ID Numbers: GCO 06-1155
Study First Received: April 18, 2007
Last Updated: June 17, 2008
ClinicalTrials.gov Identifier: NCT00462735     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Cancer of the Nasal Cavity

Additional relevant MeSH terms:
Antimetabolites
Otorhinolaryngologic Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Bone Neoplasms
Antineoplastic Agents
Paranasal Sinus Neoplasms
Paranasal Sinus Diseases
Hydroxyurea
Hematologic Agents
Physiological Effects of Drugs
Pharyngeal Neoplasms
Bone Diseases
Neoplasms by Site
Respiratory Tract Diseases
Musculoskeletal Diseases
Therapeutic Uses
Laryngeal Diseases
Nucleic Acid Synthesis Inhibitors
Respiratory Tract Neoplasms
Antisickling Agents
Otorhinolaryngologic Diseases
Cetuximab
Enzyme Inhibitors
Laryngeal Neoplasms
Immunosuppressive Agents
Pharyngeal Diseases
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on November 27, 2009