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

NCT00462735 | Completed Phase 2 Results DMC

• 1 other identifier: GCO 06-1155
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Cancer of the Pharynx; Cancer of the Larynx; Nose Neoplasms; Paranasal Sinus Neoplasms; Cancer of the Oral Cavity

Keywords

Cancer of the Nasal Cavity

Outcome Measures

Primary Outcomes (2)

• Llocoregional Recurrence

  Percentage of Participants with Loco-regional recurrence.

  2 years

• Survival

  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

  2 years

Secondary Outcomes (3)

• Long- Term Toxicity

  2 years

• UW-QOLR: Quality of Life Score

  2 years

• Distant Metastases

  2 years

Study Arms (1)

Advanced Head and Neck Cancer

EXPERIMENTAL

Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck

Drug: Cetuximab; Drug: Hydroxyurea; Drug: Fluorouracil; Procedure: radiotherapy

Interventions

Cetuximab DRUG

250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients

Advanced Head and Neck Cancer

Hydroxyurea DRUG

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

Advanced Head and Neck Cancer

Fluorouracil DRUG

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

Advanced Head and Neck Cancer

radiotherapy PROCEDURE

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.

Advanced Head and Neck Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Uncontrolled active infection unless curable with treatment of their cancer.

Sponsors & Collaborators

• Johnny Kao: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (1)

• Kao J, Genden EM, Gupta V, Policarpio EL, Burri RJ, Rivera M, Gurudutt V, Som PM, Teng M, Packer SH. Phase 2 trial of concurrent 5-fluorouracil, hydroxyurea, cetuximab, and hyperfractionated intensity-modulated radiation therapy for locally advanced head and neck cancer. Cancer. 2011 Jan 15;117(2):318-26. doi: 10.1002/cncr.25374. Epub 2010 Sep 9.

  PMID: 20830768 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Pharyngeal Neoplasms; Laryngeal Neoplasms; Nose Neoplasms; Paranasal Sinus Neoplasms

Interventions

Cetuximab; Hydroxyurea; Fluorouracil; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Skull Neoplasms; Bone Neoplasms; Bone Diseases; Musculoskeletal Diseases; Nose Diseases; Paranasal Sinus Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Urea; Amides; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Results Point of Contact

• Title: Dr. Johnny Kao
• Organization: Florida Radiation Oncology Group

johnnykaomd@gmail.com

813-661-6442

Study Officials

• Johnny Kao, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 19, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 13, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-02

Locations

US (1)