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
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
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.
- Llocoregional Recurrence [ Time Frame: 2 years ]Percentage of Participants with Loco-regional recurrence.
- 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
- Long- Term Toxicity [ Time Frame: 2 years ]Grade 3 toxicities events
- 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).
- 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|
- 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
- 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.
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
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Johnny Kao, MD||Icahn School of Medicine at Mount Sinai|
|Responsible Party:||Johnny Kao, Assistant Professor, Icahn School of Medicine at Mount Sinai|
|Other Study ID Numbers:||
|First Posted:||April 19, 2007 Key Record Dates|
|Results First Posted:||March 13, 2018|
|Last Update Posted:||March 13, 2018|
|Last Verified:||February 2018|
Cancer of the Nasal Cavity
Head and Neck Neoplasms
Paranasal Sinus Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Paranasal Sinus Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs