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Phase II Study of Concomitant Fluorouracil, Hydroxyurea, Cetuximab and Hyperfractionated Intensity Modulated Radiation Therapy for Locally Advanced Head and Neck Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Cancer of the Pharynx, Cancer of the Larynx, Nose Neoplasms, Paranasal Sinus Neoplasms, Cancer of the Oral Cavity

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Trial Information

Phase II Study of Concomitant Fluorouracil, Hydroxyurea, Cetuximab and Hyperfractionated Intensity Modulated Radiation Therapy for Locally Advanced Head and Neck Cancer


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

locoregional control

Principal Investigator

Johnny Kao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

GCO 06-1155

NCT ID:

NCT00462735

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Cancer of the Pharynx
  • Cancer of the Larynx
  • Nose Neoplasms
  • Paranasal Sinus Neoplasms
  • Cancer of the Oral Cavity
  • Cancer of the Nasal Cavity
  • Neoplasms
  • Laryngeal Neoplasms
  • Head and Neck Neoplasms
  • Nose Neoplasms
  • Paranasal Sinus Neoplasms
  • Pharyngeal Neoplasms

Name

Location

Mount Sinai School of Medicine New York, New York  10029